Job Description

Our company, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Applications are sought for an opportunity in the Vaccines & Advanced Biotechnologies - Process Research & Development (VAX PR&D) department, which is part of the company's Research Labs division of our company. The individual will support our company's discovery & development efforts for Vaccine programs at West Point, PA.

Under the direction of the Senior Director, this role will lead bulk process development efforts for protein subunit or conjugate based vaccine candidates or vaccine adjuvant candidates. The successful candidate will serve as the technical lead and people manager for a group of upstream and downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for protein subunit or conjugate vaccine or adjuvant production. These responsibilities also include the manufacture of cGMP clinical bulks and tech transfer to clinical or commercial manufacturing facilities. Duties may include pre-clinical and clinical process development, process scale-up and engineering, PAT implementation, development of innovative process monitoring and/or process control strategies, cGMP document preparation and modifications, and technology transfer to manufacturing. The successful candidate will also be responsible for representing VAX PR&D as a bioprocess expert in internal, cross-functional project teams and external conferences/consortia. This role will closely collaborate with the other Directors within VAX PR&D as well as with partner groups within analytical development (AR&D), drug product development (VDPD), enabling technologies (ET), discovery, and commercialization (BDSC).

Primary responsibilities include, but are not limited to:

• Technical lead and direct or indirect people manager of a team (10-20 scientists)

• Develop program strategies and guides future technological investment activities based on regulatory and industry trends.

• Advance a culture of scientific excellence, by serving as a subject matter expert (SME) in the areas of protein subunit, conjugate, or adjuvant production process development, characterization, and technology transfer.

• Drive the development of new principles, concepts, and methods to enable accelerated process development, process scale-up, and technology transfer to meet program deliverables.

• Support/lead strategic initiatives and drive innovation in vaccine and advanced biotechnology process development.

• Represent functional area in cross-functional and strategic teams engaged in in novel vaccine and advanced biotechnology development.

• Actively network with both internal and external counterparts (i.e. biopharma industry, academia).

• Engage with the VAX PR&D leadership team and multidisciplinary DSCS teams to advance departmental strategic and cultural initiatives.

• Identify, recruit, onboard, and develop employees within the VAX PR&D organization.

• Provide mentorship, technical oversight and strategic guidance to direct reports.

• Perform proactive resourcing planning and establish viable succession plans for key positions.

• Ensure cGMP compliance and operational excellence in the laboratories.

• Author/review required regulatory and technical documentation.

• Handle multiple priorities and balance work to achieve business goals.

The successful candidate will be expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to maintain focused attention on compliance training and laboratory safety for his/her team.

Travel may be required.

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences

Required Experience and Skills:

• For BS, at least fourteen (14) years of experience in biotechnology related position

• For MS, at least twelve (12) years of experience in biotechnology related position

• For PhD, at least ten (10) years of experience in biotechnology related position

• Must have strong scientific understanding of process development principles.

• Excellent scientific understanding of CHO cell culture, polysaccharide or peptide conjugation, and/or nano-emulsion or liposome production

• At least 8 years of hands-on experience in protein, conjugate, or adjuvant product process development.

• Prior experience of statistical design of experiments

• Strong understanding and experience in technology transfer and cGMP manufacturingat clinical or commercial scale

• Experience in mentoring/managing teams of scientists/engineers

• Sound understanding of the regulatory guidelines governing cGMP manufacture

Preferred Experience and Skills:

• Prior experience in CHO cell culture and protein purification process development

• Prior experience in protein subunit-based vaccines

• Prior experience in polysaccharide or peptide conjugation process development

• Prior experience in liposome, nano-emulsion, or lipid nanoparticle production process development

• Strong foundation in engineering principles and their application to bioprocess unit operations

• Prior experience in the development of lab, pilot, and commercial scale processes

• Prior experience in implementing PAT approaches to solve bioprocess challenges

• Project management experience including participation or preferably leadership of technical working groups

Your role at our company 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 our company, we're inventing for life.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R335173