Senior Scientist, Biologics Analytical Technology

Job Description

Requisition ID: BIO005113

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 Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

We are seeking a motivated and experienced Analytical Scientist to join the Biologics Analytical Technology group in West Point, PA. The position is within Biologics and Vaccines Analytics and provides technical support for analytical methodologies used in testing of commercial products.

• Performing experimental and technological investigations directed toward gaining new knowledge, specifically related to new bio-analytical technologies
• Provide authorship or review of analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs and regulatory submission documents.
• Contribute to investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs.
• Provide documentation/technical input during inspections and audits.
• Have a working knowledge of data integrity and recent industry trends.

Qualifications

Education:

• PhD with a minimum of 2 or more years’ experience in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, Biophysical Chemistry or related fields of experience OR
• MS with a minimum of 5 or more years of experience in Pharmaceutical Sciences, Biochemistry, Bioengineering, Biophysical Chemistry, Chemical Engineering, or related fields.

Required:

• Direct experience with commercial monoclonal antibodies
• Working knowledge of developing bioassay methods, including ELISA and Cell-Based Methods to support drug substance and drug product development and registration.
• Experience with Functional Cell-Based Assay Development and Validation.
• Experience with Critical Reagents associated with Bio-analytical testing.
• Working experience with CMO’s and CRO’s.
• Strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
• Strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• Ability to raise issues, when necessary, to drive these to resolution.
• Skills in identifying and managing risks.

Preferred:

• Experience with Quality and Regulatory Requirements
• Working knowledge of data integrity and recent industry trends
• Working knowledge of CMC filing requirements.

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:

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Job: Biologics, Vaccines, Analytical Formulat
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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