Principal Scientist - Biologics Analytical Program Lead
- Kenilworth, NJ
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough.
The Analytical Program Lead (APL) serves as the primary point of contact for all analytical activities within the Biologics Analytical Research and Development (B-AR&D) organization. The qualified candidate will be responsible for the development of a program specific analytical strategy and management of analytical timelines and deliverables for monoclonal proteins or other complex therapeutic proteins from clinical candidate through commercialization. Responsibilities include oversight of method development, testing, stability, extended characterization, FD/ICI (forced degradation/impurity characterization and isolation), in-process, formulation etc. through the coordination of cross-functional analytical representatives at working group meetings. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams.
- Develop the analytical strategies and manage all analytical deliverables for a given program(s) in a matrix team environment.
- Serve as the single point of contact and enable an effective partnership with key stakeholders including Upstream/Downstream Process Development, Formulations, Global Clinical Supply, Chemistry, Manufacturing & Control (CMC) Regulatory, Quality, Commercial-facing Partner Groups, Management and Governance teams.
- Prepares and/or provides oversight on the drafting of technical communications and other source documents to support regulatory filings.
- Coordinates development, optimization and pre-qualification activities of analytical methods.
- Facilitates method establishment, interaction and transfer to internal and external partners.
- Partners with Development and Commercialization Team (DCT) representatives to support QbD (Quality by Design) activities and lead pCQA (proposed critical quality attribute) and analytical risk assessment discussions.
- Serves as the primary lead in the development of phase appropriate Drug Substance and Drug Product specifications.
- Develop a central repository for knowledge and life-cycle management of the program.
Education Minimum Requirements:
- B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals or related field with 14 years of relevant experience; or M.S. degree with 10 years of relevant experience; or Ph.D. with 8 years of relevant experience.
Required Experience and Skills:
- Extensive experience in biochemical, biophysical and biological activity-based assays.
- Effective communication and leadership skills in a dynamic environment.
- Strong knowledge of biologics CMC requirements and experience in supporting health authority filings.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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