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Executive Director, Bioprocess Clinical Manufacturing & Technology

Merck

Merck

IT
West Point, PA, USA
Posted on Thursday, June 6, 2024

Job Description

Our department Vaccines and Advanced Biotechnologies (VAX) Process R&D in Development Sciences & Clinical Supply (DSCS) is responsible for the development and clinical manufacturing of DS for the vaccine pipeline, spanning from preclinical to commercialization stage. We are part of the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline.

We are seeking an esteemed leader for the GMP manufacturing of vaccine and biologic drug substances (DS) as the Executive Director for the Bioprocess Clinical Manufacturing & Technology (BCMT) organization, based in West Point, PA. The leader is responsible for the management of a GMP pilot plant and clinical supply for all of vaccine and select biologics DS within the company, as well as drive operational excellence and technological innovations in GMP manufacturing.

The individual will report directly to the Associate Vice President of VAX Process R&D and will be expected to expertly represent the group on certain capacities, including but not limited to due diligence, regulatory input, and program leadership. The role will also serve as a key mentor for the development of scientific and operational talents from diverse background and advance our company's commitment to a diverse and inclusive work environment.

Primary Responsibilities:

  • Manage a large organization (80-100 staff) of exempt and union employees responsible for the manufacture of bulk clinical supplies for vaccine and select biologic candidates.

  • Manage Biologics Pilot Plant (BPP) for bulk clinical manufacturing and cell bank/ seed preparation for vaccines and (select) biologic programs, with responsibilities including raw material / culture media planning, manufacturing (or out/in-sourcing), and release coordination; process automation; sterile component manufacture; SOP and GMP document management; capital project management and support; facility housekeeping and warehouse management.

  • Serve as the department’s representative for WP (West Point, PA) site-wide Executive Council, WP Site Governance team, and Global Quality Council Committee.

  • Responsible for close liaison with the company's Manufacturing Division to be alert to opportunities for research and development leading to major economical process changes.

  • Coordinate the demonstration of new processes with Manufacturing Division and its manufacturing sites in preparation for production; and collaborate with Manufacturing and CMC Regulatory in the preparation of regulatory filings for commercial products.

  • Plan and direct programs to bring out new products for the Company by developing safe and rapid production methods which will result in the economic manufacture of products having commercial utility.

  • Responsible for the proper coordination of laboratory programs with Pilot Plant demonstrations which result in the procurement of manufacturing data and the immediate preparation of experimental quantities of new products to supply material vital for laboratory research, pharmacological research and clinical and field investigations.

  • Directs the preparation of and approves disclosures prepared within BCMT to be used as the basis for patent applications.

  • Plans, prepares and submits technical programs within responsibility for budgetary approval annually.

  • Leading operational excellence initiatives at BCMT. Align metrics, best practices, and standards across with other GMP pilot plants in PR&D to ensure Right First Time, efficient and compliant operations.

Education:

  • Bachelor in microbiology, biochemistry, chemical engineering, or a relevant field.

Required Experience and Skills:

  • 10+ years of drug substance development and clinical manufacturing experience

  • Strong knowledge and expertise in vaccine development and CMC development, with a track record of leading Product Development teams and CMC development teams.

  • Strong GMP background, including validation, qualification, manufacturing environment

  • Strong safety/environmental knowledge and site presence.

  • Ability to grow and develop an organization, build the best team and grow talent.

  • Ability to collaborate across organizations/ division.

  • Ability to develop, implement, refine long range operating plan and drive a vision

  • Demonstrated ability to lead and drive operational excellence initiatives.

  • Excellent communication (both written and verbal), leadership, and influencing skills.

  • Based in West Point, PA is required.

Preferred Experience and Skills:

  • Extensive hands-on experience in vaccine process development, clinical and commercial manufacturing, as well as Quality oversight.

  • Solid experience and proficient with major cell substrates (E. coli, yeasts, HEK293, Vero, CHO, sf9) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, and biologics).

  • Strong knowledge of global regulatory, quality and manufacturing requirements for vaccines and biologics.

  • Working knowledge on Drug Product Intermediates and adjuvant development and manufacturing.

  • Experience in navigating complex governance processes and facilitating decision-making.

  • Resourceful leadership in mentoring and advocating diversity, equity and inclusion for talent development.

  • Ability to manage multiple conflicting priorities and use multiple negotiation styles.

  • Capital experience for large building projects.

  • Demonstrated expertise in change management.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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:

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EEOC GINA Supplement​

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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.

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, generally Tuesday, Wednesday and either Monday or 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”.

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:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/15/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:06/15/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R298812