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Posted by: Merck & Company on May 30, 2019


Location:

Kenilworth , NJ

Job Description:

Requisition ID: BIO005462

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Position Description
The Analytical Program Lead (APL) serves as the primary point of contact for all analytical activities for specific Biologics programs. The qualified candidate will be responsible for the development of program-specific analytical strategy and for management of analytical timelines and deliverables for monoclonal antibodies or other complex therapeutic proteins from preclinical candidate through late phase filing. Responsibilities include oversight of method development, testing, stability, extended characterization, forced degradation studies, isolation and characterization of impurities, in-process testing, and formulation development support 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.

Responsibilities:
Develop the analytical strategies and manage all analytical deliverables for 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, Formulation Development, Global Clinical Supply, CMC Regulatory, Quality, Management and Governance teams
Prepare and/or provide oversight on the drafting of technical communications and other source documents to support regulatory filings
Coordinate development, optimization and pre-qualification activities of analytical methods
Facilitate method establishment and transfer to internal and external partners
Partner with CMC Team representatives to support QbD activities and lead pCQA and analytical risk assessments.
Serve as the primary lead in the development of phase appropriate Drug Substance and Drug Product specifications
Develop a central repository for key product knowledge and strategic decisions throughout the life-cycle of the program


Qualifications

Education Minimum Requirement:
B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals or related field with 10 years of relevant experience; or Master's degree with 7 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Required Experience and Skills:
Extensive experience with analytical methods applied to biologics such as monoclonal antibodies or other therapeutic proteins.
Effective communication and leadership skills in a dynamic environment.
Strong knowledge of biologics CMC requirements and experience in supporting health authority filings.

Preferred Experience and Skills:
Demonstrated capabilities in project management.
Experience with a wide variety of methods, including biochemical, biophysical and biological activity assays.
Experience in setting of release specifications.


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.

Job: Biologics, Vaccines, Analytical Formulat
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck

Pay Rate:

Unspecified

HR. Website URL:

https://jobs.merck.com/search/?q=&startrow=1

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About Merck & Company

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century.

Please visit this employer's Public Profile to see more jobs offered by Merck & Company