Sr. Scientist, Biologics Pilot Plant Capital Group Job

Sr. Scientist, Biologics Pilot Plant Capital Group-BIO004936

Description

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.

Applications are sought for a position in MRL’s Biologics Pilot Plant (BPP) in the clinical operations area.

Responsibilites will include but are not limited to:

- Managing capital projects in support of biological clinical manufacturing in the pilot plant

- Candidate will have responsibility for a range of activities including:

- Capital planning and forecast,

- managing both small and large capital projects,

- engineering design,

- representing process requirements from design through to installation,

- commissioning, qualification and transfer to operations,

- conducting safety reviews & HAZOPs,

- developing SOPs and providing leadership for a wide range BPP GMP, environmental, and safety/biosafety initiatives associated to capital efforts.

- Candidate will also participate in regulatory (GMP and environmental) inspections.

In addition to the core responsibilities outlined above:

- An opportunity exists to contribute towards defining/streamlining various business processes for efficient and flexible management of a multi-product facility for the manufacture of clinical supplies for products in all phases of development.

- Solid understanding of the engineering guidelines and associated cGMPs, safety/biosafety, and environmental expectations is required.

- Hands-on operational equipment and preventative maintenance knowledge are expected.

- Candidate is expected to work in a team atmosphere in close collaboration with various groups within the area (fermentation/cell culture, purification, automation/processing, and documentation) and key support areas such facility engineering, quality engineering, GMP compliance, environmental and safety groups.

Qualifications

Education:

- A Bachelor's Degree in Engineering with a minimum of seven (7) years relevant experience, OR a Master's Degree in Engineering with a minimum of four (4) years relevant experience, OR a PhD in Engineering.
Required:

- Previous experience in processing of biologics, GMP operations, safety / biosafety, environment is required.

- Strong organizational, planning and communication skills are essential.

- Ability to work independently or in a team environment is expected.

- Periodic overtime will be required
Preferred:

- Experience in mechanical system, process system, and process control design.

- Quality Development systems and cGMP experience.

- PLC and/or DeltaV experience.

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 an accommodation for the application process please email us at 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.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Biological Manuf-Pilot Plant

Job Title:Sr. Scientist, Biologics Pre Manf

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: No

Number of Openings: 1

Hazardous Materials: Yes, depends on the program being supported

Company Trade Name:Merck