9 Biotech jobs

ESSENTIAL DUTIES AND RESPONSIBILITIES: Prepare isolated adult animal cardiomyocytes for contractility assays Use pre-established experimental designs to plan, and execute myocyte contractility and Ca2+   transient assays Be responsible for data collection, organization and record keeping Identify, communicate and triage assay anomalies during data collection or analysis of experimental results Propose solutions to technical issues: proactively seek out senior team member to discuss potential resolutions to problems Collaborate with colleagues and team members to provide robust data Understand and follow IACUC approved protocols for animal use Flexibility to start (and leave) work early 2-3 times/week to initiate protracted experiments (~7:00 AM)   EDUCATION/EXPERIENCE/SKILLS:  Education: Requires a BS in physiology, pharmacology, or related discipline.   Experience: Minimum of 1-2 years of animal handling experience in a pharmaceutical industry or academic research lab setting Experience in pharmaceutical science, preferably in pharmaceutical industry focusing on cardiovascular science. Familiarity with cellular electrophysiology advantageous, but non-essential Technical Skills: Hands-on experience with animal handling (mice and rats), and tissue collection, particularly heart. Ex vivo adult rat cardiac myocyte isolation and myocyte contractility experience a plus  

Essential Responsibilities Develop a comprehensive understanding of the market environment, including market penetration, market potential, and future trends Manage primary & secondary market research studies, including project objectives & design, vendor selection & oversight, monitoring of data collection & analysis, and interpretation, across multiple customer groups Integrate key market dynamics and cross-functional expertise into revenue forecasts Build, refine, pressure-test, and present revenue forecasts that support decision-making processes for key cross-functional partners Develop relevant and compelling presentations of market research insights, revenue forecasts, and recommendations that drive key strategic and tactical decisions for cross-functional partners Manage ongoing business relationships with vendors, consultants and selected partners; manage complex projects within budget and timeline   Knowledge & Skills Experience designing and conducting quantitative and qualitative market research across multiple customer groups, including but not limited to physicians, patients, allied health care professionals, pharmacists, and advocacy groups Experience in building & maintaining forecast models as well as a firm grasp of complex forecasting & modeling techniques that support various types of strategic analytics; experience in generating commercial insights from pharmaceutical datasets Strategic thinker who understands the critical role of market research & forecasting in developing commercial strategy in support of a product launch; ability to operate in ambiguous situations and determine focused objectives and a clear path forward in the face of open questions Balance of exceptional technical expertise with strong strategic thinking and practical business orientation; strength in finding and focusing on key business drivers Ability to analyze complex issues, distill information to essential knowledge, develop business-relevant strategic recommendations, and persuasively present to a range of stakeholders Highly developed interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of backgrounds Ability to multiple manage projects and timelines for both internal initiatives and with external vendors Must have a proven ability to sustain a high energy level over time   Education & Experience BA, BS required. Master’s degree in business or science preferred 3 to 7 years of market research/forecasting experience in the bio/pharmaceutical industry Launch experience is preferred Previous consulting & recent bio/pharma experience is preferred  

Summary: This person reports to the Director of Technical Operations and Clinical Supply Chain. This role will allow the ideal person to be exposed to new methodologies.  Essential Functions These may include, but are not limited to, the following; other duties may be assigned: Develop clinical study supply plans and maintain active inventory tracking for both clinical and placebo investigational drug products in compliance with company’s internal procedures and GxP requirements. Have experience and knowledge of executing Phase I – III protocols. Prepare clinical trial material forecasts at the study level and track material inventory, update use and expiry dating to ensure uninterrupted delivery of clinical study supplies. Proactively highlights to management when action is indicated.  “Actions” may include a shelf life extension or resupply submission to health authorities are necessary. Have experience and thorough understanding of IXRS/IRT systems and trial execution using these systems. Participate in global clinical drug supply activities associated with the team’s trials (secondary packaging vendor selection, technical batch record review, QP Release coordination, clinical label design, packaging and labeling, IRT efficiencies) Vendor Management – Prioritize labelling and packaging activities at CROs/CMOs, when packaging operations for clinical trial material are in-process. Establish the packaging design based on protocol and manage all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors Ability to coordinate CTM shipping and logistics activities including management of shipments of CTM from between storage/distribution sites and to clinical trial sites Ability to coordinate courier deliveries and shipments, and manage the courier relationship.  Oversee packaging of materials according to IATA or DOT dangerous goods regulations. Oversee special projects including international shipments with awareness of required US Government certificate / license, if applicable, for worldwide shipment of investigational clinical trial material, drug substance, and drug product. Review temperature logs for CTM distribution and storage and investigates temperature deviations according to SOP Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with co-workers and functional areas to accomplish project objectives. Participates on clinical sub-teams and provides clinical supply updates and summaries to management. Supports management with implementation of departmental strategies and policies. Qualifications BS or Master’s Degree in life science, or related field (or equivalent experience) 8-10 years’ experience in GMP clinical supply chain, supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization. Preferably Certificate in Supply Chain Management Program Ability to work independently to make strategic decisions related to planning, and budgeting. Understanding of cGMP’s and pharmaceutical industry procedures and regulations Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project management experience Hand on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software Strong, open and transparent communication skills (verbal and written) Solid organizational and time management skills Project management skills and computer proficiency Experience with: MS Excel, Word Ability and willingness to travel 10% of the time (internationally and domestically)

Position Summary: The Manager of SEC Reporting and Technical Accounting is responsible for all SEC financial reporting activities and technical accounting analysis. This individual will frequently interact with accounting staff, IT, legal, and other stakeholders across the organization as well as external SOX consultants and external auditors. This role requires critical thinking skills, effective organizational skills, excellent written and verbal communication skills, and a strong ability to build effective relationships across the Company. This position offers the successful applicant the opportunity to  leverage a strong background in external reporting, technical accounting and Sarbanes-Oxley compliance with the dynamics of a growing biotechnology company.  Responsibilities: Lead the timely and accurate preparation of Company’s SEC filings, including 10-Qs and 10-Ks, ensuring appropriate XBRL tagging of related content in Active Disclosure. Gather supporting data, tie outs and preparing information for review. Create and maintain SEC calendar, coordinate key timelines as well as deliverables and inform parties of necessary deadline adherence for the following processes: financial close, BOD package, press release and 10-Q/K Ensure financial statements are presented in accordance with GAAP guidelines. Proactively identify accounting & disclosure issues and perform related research and documentation of such issues in accounting whitepapers; propose suitable disclosures and benchmark against industry standards. Maintain relationship and work closely with External Auditors, Business Owners and Senior Management to ensure communication of critical issues in a timely manner. Coordinate/monitor/review the execution of audit procedures related to financial reporting and technical accounting topics. Partner with SOX consultants in documentation of SOX Risk Assessment, Risk Matrix, Process Documents, Testing Protocol, and Review Testing for financial reporting and other related cycles. Support the assessment of internal controls over financial reporting in according with the COSO Framework and Sarbanes-Oxley Act (SOX). Stay abreast of new accounting principles, SEC reporting and general trends. Participate in special projects and perform additional duties as required. Education and Professional Qualifications: Deep subject matter expertise in SEC reporting, technical accounting and US GAAP accounting standards CPA required, with a Masters in Accounting or MBA preferred Minimum of 6 years of relevant work experience to include 4 years for a Big 4 public accounting firm, followed by experience in SEC reporting for a publicly held, 404(b) compliant, large accelerated filer. Experience in preparing SEC financial filings for a public company, including use of an SEC filing platform, such as Active Disclosure Exceptional leadership and teamwork capabilities Excellent oral and written communications skills Strong personal drive for excellence and highly self-motivated with strong work ethics Well-developed problem-solving skills combined with experience working with outside consultants in a positive and collaborative manner. Enjoys being ‘hands-on’ and taking ownership of processes Able to work in an environment where sharing responsibility for success and mitigating the shortcomings of others on the team is critical to the overall success of the Company. Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings. Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions. Role model for MyoKardia’s values.  

Senior  Clinical Trial Leade r  (Sr. CTL) SUMMARY:     The Senior Clinical Trial Leader  ( Sr.CTL )   a cts as a  senior  clinical trial lead on one or more clinical studies.  He/She  d evelops, manages and coordinates all clinical trial activities for their studies including managing Clinical Research Organizations ( CROs ) , vendors and internal team members. The Sr CTL d evelops and applies best practices in the development, initiation, planning, execution, control and closing of projects.   He/She  is a proficient communicator  and effective influencer  who builds and maintains strong relationships internally and externally.   All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.   ESSENT IAL DUTIES AND RESPONSIBILITIES: Lead more than one or highly complex, adaptive or pivotal studies Plan   and execute studies from feasibility to close out, accountable for all study budgets, documents , drug supply, and plans with 3- year horizon Select countries and sites based on Clinical Development Plans and global Strategies Conduct program level feasibility and develop recruitment plans Actively lead  cross functional team  and  attend Clinical Sub Team/Project Team meetings as needed to represent Clinical Operations Create and maintain performance and quality metrics Contribute clinical information for Regulatory submissions and responses Proactively identify risks and devise mitigation plans Expert in complex vendors and relationships Select CRO, other vendors, manages  Scope of Work ( SOW ) , scope changes, budgets, approve all vendor payments .   Ensure that CRO has strategic direction for protocol(s) Hold  vendors accountable to  Scope of Work ( SOW ) Responsible for contributing to and delivering study and therapeutic area training for team and vendors Accountable for I nvestigator  M eeting s, oversee  planning Accountable for ensuring data quality and timely data reviews conducted May attend qualification or Site Initiation Visit Develops and drives site engagement strategy Highly skilled communicator, builds & maintains strong relationships internally and externally Drive protocol & amend ments Investigator Brochure, Informed Consent Form , monitor plans, risk management Reviews clinical sections of other regulatory documents e.g. annual or periodic safety reports, IND/NDA filings for quality and consistency Build  compelling, data driven case, clearly articulates vision to business partners, CROs,  etc Provides supervision, coaching and mentoring to new study leaders,  CTMs  and Associates Responsible for growth, development, and promotion of full time direct reports using development planning tools .  Contribute to hiring of new staff. Master of Clinical operations, can lead any study  and is a protocol expert Understand and apply  knowledge of science/biology, e.g. cardiology, mechanism of action of drug to planning and all phases of the study Seek  to stay current with new advances, competition Accountable for complete Trial Master File  and training of study team, internal and external business partners   Supervisory r equirements Directly supervises 1-3 employees May  be responsible for external consultants   EDUCATION/EXPERIENCE/SKILLS:   BS/BA required . MS/MA degree in related discipline desired . Typically requires a minimum of 8 years of related experience and/or combination of experience and education/training research in the biotechnology/pharmaceutical industry. Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities . Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management .     Knowledge/Skills/Abilities : Thorough clinical research knowledge and cross-functional understanding of clinical trial methodology is required. Knowledge of ICH-GCPs and 21 CFR is required . May lead or oversee the work of others by providing direction  and by  using established policies and precedents. General project management skills with the ability to organize, prioritize and manage numerous tasks and complete them under time constraints. Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques. Proficient with broad use computer applications such as MS Office and specialized applications as needed for job. Ability to travel up to 25%     JOB COMPLEXITY: Performs job duties with minimal guidance from supervisor . Works on problems of complex scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Creates formal networks involving coordination among groups.   VALUES: Patients first Passion for science Succeed together Imagine and innovate Lifelong learning  

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.  Our vision : We strive to be the leading supplier using science and technology to improve the quality of life. Our mission : We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? A the Drug Product Manager you will provide technical expertise in the areas of aseptic processing and fill/finish, commercial product life cycle management, drug production technology transfer, primary packaging, visual inspection and process analytics.  The candidate will identify risks and drive continuous process improvements through technological and operational innovation for drug product manufacturing processes.   In this position, he/she will lead the technical team responsible for Tech Transfer and be responsible for the management of commercial and clinical drug product supply.  You will partner with clients and internal groups to establish robust technical working relationships related to the commercial and clinical manufacturing of sterile drug production.  Aid in the review of new client proposals, the selection and introduction of new drug productions, the evaluation of current and new parenteral liquid filling lines.  Lead the design, development and technology transfer for new and existing manufacturing processes.  Develop processes to monitor and manage the day to day interaction of drug product manufacturing operation to ensure clinical and commercial supply. Requirements Bachelors of Science in Biological Sciences or Biomedical/Chemical Engineering, Miocrobiology/Biology. Masters of Science or Engineering or PhD preferred 8+ years of biotech industry experience involved in drug product manufacturing, Fill-finish, aseptic techniques.  Experience with large scale manufacturing support (biologics drug product, viral vector, cell/gene therapy) preferred In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements Ability to work independently and follow through on assignments and delivery of the site strategy without direction. Perform within a dynamic and stressful environment and remain calm under pressure Ability to maintain attention and concentration Ability to analyse problems, practices or procedures in order to define the problem or objective, identify relevant concerns or factors, identify patterns, tendencies and relationships and formulate logical and objective conclusions and recognise alternatives and their implications. Professional interactions with customers, senior leadership and colleagues Offer alternate views and options to opposing direction as well as understanding the obstacles Ability to ensure decisions made are beneficial to the business and the team Strong Leadership skills – strong communication, technical writing, organization and interpersonal skills.  Demonstrates critical thinking skills in problem solving and decision making. Attention to details and high level of accuracy. The capacity to inspire and motivate a large team in the achievement of specific objectives Effectively presents information and ideas formally and informally, verbally and in writing to others. Ability to communicate status, needs, forecasts, risks and timelines effectively across the organization Strong actively listening skills and ability to work collaboratively to achieve objectives.  Practices safety awareness at all times and considers implications prior to actions Responsibilities He/She will provide technical expertise in the areas of aseptic processing and fill/finish, commercial product life cycle management, drug production technology transfer, primary packaging, visual inspection and process analytics.  The candidate will partner with clients and internal groups to establish robust technical working relationships related to the commercial and clinical manufacturing of sterile drug production.  The candidates will aid in the review of new client proposals, the selection and introduction of new drug productions, the evaluation of current and new parenteral liquid filling lines, lead the design, development and technology transfer for new and existing manufacturing processes.  He/She will develop processes to monitor and manage the day to day interaction of drug product manufacturing operation to ensure clinical and commercial supply. Training team and serving as the SME of aseptic processing procedures Client Facing:   Engage with Program Managers and directly with customers to ensure projects are planned and executed appropriately in order to deliver and meet the needs of the business and the clients. Senior Leadership Interactions: Engage, interact and communicate with the site leadership Team through meetings, Councils and the DMS to ensure sit and is aligned with Business and customer expectations. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza.  The place to Go, Stay and Grow.

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.  Our vision : We strive to be the leading supplier using science and technology to improve the quality of life. Our mission : We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.   Do you want to help us as we shape the future of this great organization? Single point of accountability with authority to execute activities and management resources necessary for production plan achievement.  Lead the department, managing safety, quality, compliance and efficient, product delivery, batch release, and financial execution.  Empowered to reach across functional areas and across phases of execution. Participate in site strategy decisions as a part of the site leadership team for Portsmouth. As a member of the site leadership team, lead cross-functionally with management, support departments, and customers to achieve site vision and strategy. Ensure that the manufacturing facility is in a continuous state of readiness for production and GMP audits. Supervise, train and mentor the manufacturing management team. Create a high-performance team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.  Focus on people development, identification and development of successors and High Potentials. Perform other duties as assigned.  Safety Responsibility Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.  Must comply with safety policies of the company and site.  Employee owns their own safety and the safety of others. Quality Responsibilit y Adherence to cGMPs is required at all times during the manufacture of APIs.  All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions. Environmental Demands The normal working environment is: Production Floor setting, requiring PPE, gowning, safety shoes and glasses. Mental Demands Must have the ability to comprehend process flow and identify factors which influence the process. Must be able to read and follow defined SOPs and policies, work independently and as part of a team on various manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with Management. Must be able to use automated process equipment and tools.   Lonza is an equal opportunity employer. All qualified applicants will receive consideration or employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza.  The place to Go, Stay and Grow.

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.  Our vision : We strive to be the leading supplier using science and technology to improve the quality of life. Our mission : We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary The Head of Emerging Technology Operations is responsible to direct the production of therapeutic proteins (API) under cGMP conditions overseeing a Site within a Site area; managing safety, quality, compliance and efficient, product delivery and financial execution. Primary Accountabilities, Duties and Responsibilities: Lead a dedicated management team with full accountability for asset profitability and success.  Clear accountability for performance improvements and delivery.  Direct responsibility for the operations team and lead via a matrix organization for functions providing support to execution including Engineering, Facilities, EHS, PM, QA, MSAT, QC, PPL. Serving as an integral member of the Site Leadership Team (SLT) the incumbent will be responsible for leading the execution of the management team, business partner and functional management teams.  Incumbent will be responsible for collaborating with customers in delivering a safe and compliant operation both internally and externally. Drive continuous improvement activities, strategy development and delivery, as well as supporting organizational development and cultural leadership. Collaborate with Quality Assurance to develop, modify, implement and operate quality systems aligned with Lonza standards. Responsible for attracting and retaining skilled talent; training and encouraging a team-centric environment that improves business performance. Must be capable of motivating others, creating a positive work climate where inter-departmental collaboration, coaching and performance feedback are continuous.  Capable of clearly assigning objectives, clearly setting and measuring and monitoring progress, marshaling resources and handling competing priorities. Experienced at establishing clear directions, leading others and bringing out their best. Minimum Qualifications/Skills: BS in Science related discipline: Biotechnology, Biology, Chemistry Expertise in manufacturing with management/associate director experience: GMP experience and API manufacturing experience strongly preferred.  Requires excellent project management skills with systematic approaches to problem solving.  Ability to break down complex problems and tasks into activities capable of being performed by personnel. Experience with 6S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred Proven logic and decision-making abilities, critical thinking skills. Demonstrates effective leadership Ability to work inter-departmentally and with customers.  High level of suite specific operations and technical skills.  Demonstrates role model EPS behaviors- e.g. 3 way communication, questioning attitude Demonstrates role model safety behaviors Strong written and verbal communication skills Demonstrate ability for effective Planning, Organizing and Controlling competency Demonstrate sound decision making, considering broad scope of factors Ability to communicate effectively at all levels in verbal and written form.  Able to manage multiple cross-functional teams simultaneously. Exceptional leadership, interpersonal communication, negotiations, collaboration and management skills. Ability to effectively prioritize and direct tasks in a fast-paced environment is critical. The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities.  Is open to and actively seeks out feedback on their performance and translates that feedback into action. Ability to lead, organize and direct complex activities in a broad cross-functional setting.  Ability to integrate broader teams to ensure singular focus. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.  Lonza.  The place to Go, Stay and Grow.

Job Overview: This role is an exciting opportunity to be a part of our Pharmaceutical Staffing team of our Schaumburg, IL office; supporting the clinical research and development areas within the drug, device and biotech industries. Our Pharma division continues to rapidly grow and we are seeking experienced  Clinical Recruiters  to join us in our continuous strive for greatness.  We are looking for qualified candidates with a passion for establishing and building strong relationships and those who have a true interest in learning more about the industry, market trends, and candidates. We work as a team, we believe in striving for excellence, and we are passionate in our pursuit of the best talent in the industry. Named one of the fastest growing companies in the nation by Inc. Magazine, The Execu|Search Group offers each individual room for their own growth while also fostering a team environment. Below are a few reasons why you should consider an opportunity at Execu|Search!   On-going training as well as abundant career development resources for all employees We strive for a constant work-life balance for all employees Heavy emphasis on promotional and incentive opportunities We like to have fun with things like office ping pong tournaments, jeans days, Happy Hours, Summer Friday’s, and company sports teams, to charity runs/walks and firm-wide community initiatives, Execu|Search promotes teamwork and believes in rewarding hard work. Competitive Base Salaries and Uncapped Commissions We discourage bureaucracy and give each of our team members an opportunity to develop a voice at the firm Job responsibilities include, but are not limited to the following: Manage high volumes of job orders from mid-senior level searches -  both full-time and contract Create robust sourcing and recruitment strategies on a daily basis Build talent pipelines through networking, employee referrals, cold-calling and other creative channels –  exceptional sourcing skills Conduct in-depth talent phone screens, in-person interviews, and facilitate internal team discussions regarding candidates Communicate both client organizational information, job opportunity details, pre-close, negotiate and finalize offers Demonstrate commitment to being seen as a true ‘career advisor’ to both job seekers and clients We are looking for individuals with: 2 or more years of recruitment and/or staffing experience, in the areas of Clinical, Pharmaceutical, or Healthcare Staffing agency setting preferred Excellent communication and interpersonal skills, particularly in relationship building and follow up Ability to think strategically, execute effectively, and deliver high quality work against tight deadlines Strong motivation for personal success **This role is Base Salary + Uncapped Commission **