Job Description
Our company 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 our company has codified its legacy for over a century. our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our company is on a quest for cures and is committed to be the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
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Our company is seeking a highly motivated candidate for the position of Director, Vaccine Drug Product Development. Vaccine Drug Product Development (VDPD) team is responsible for the research and development of vaccine drug products and various innovative technology platforms. The candidate will lead and direct the development for a range of vaccine modalities within our company's portfolio including live viruses, subunits, conjugates, VLPs, nucleic acid-based vaccines and be engaged in adjuvant development.
The successful candidate:
- Should have a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory environment, and competence to influence the functional partners and regulatory environment
- Will effectively team with VDPD leadership and extended leadership teams to implement strategy, direct phase appropriate research & development from the laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for vaccine development processes for human health
- Will be responsible for sub-functional strategic planning, coordinating, and execution of VDPD initiatives for our company's portfolio from discovery to launch.
- Will need to collaborate in a fast-paced, integrated, multidisciplinary team environment with key stakeholders across the organizations such as Quality, Regulatory CMC, and technical functions, to ensure development of robust & scalable processes, timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance functional impact.
- Will drive disruptive innovation technologies while developing new ways of working to meet aggressive timeline requirements and integrate within the portfolio, where appropriate.
- Will be responsible for review of potential DP CMO opportunities, engage in technology transfer to commercial sites, and support manufacturing efforts including CAPAs, process monitoring, robustness, and characterization
- Will complete necessary phase appropriate risk assessments, and support regulatory filings including INDs/IMPDs and NDAs
- Is expected to have a strong network internally and across the external academic and regulatory community, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development
The Director will report to the Executive Director of Vaccine Drug Product Development, have 3 - 5 direct reports and will be responsible for a team of 10-20 senior and associate level scientists. The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision to their full potential. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.
Essential Knowledge, Duties & Responsibilities for the Director Include:
- Sterile drug product development concepts, tools, and technical/ operational/ regulatory requirements for all dosage forms (liquid, lyo, drug-device combinations)
- Review and approval of data and technical documents
- Ability to recruit, select, develop, and mentor talent.
- Strategic and critical thinking to advance VDPD strategy
- Project management skills
- Builds collaborations across internal our company's departments and key stakeholders.
- Ability to lead and champion organizational structure and be a change agent when necessary.
- Developing the departmental budget and meeting the agreed upon spend.
- Collaborates and builds strong relationships with upper management and other disciplines to select and qualify new CMOs/CROs/CDMOs
Qualifications:
Education:
- Ph.D. in pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, chemical engineering, biology, virology, or relevant field with minimum of 8 years of industrial experience.
- B.S. or M.S. in biochemistry, biology, chemistry, pharmaceutical sciences, biochemical / biomedical engineering, chemical engineering, or relevant field with minimum of 12 years of industrial experience
Minimum Qualifications Include:
- Experience developing subunit and conjugate vaccines through all stages of product development.
- Knowledge of adjuvant science including evaluations, development and manufacturing of adjuvant systems
- Experience in developing liquid, lyophilized, injectable drug product formulations and/or Drug Delivery and Technology initiatives.
- Experience with design of injectable sterile drug products including drug-device combination products for biologics or vaccine modalities (e.g. live virus vaccines, adjuvants, subunit, conjugated, RNA based)
- Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams & engineering drawings
- Process development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools.
- Experience with regulatory submissions including writing / review of regulatory filings including INDs and BLAs.
- Must be innovative and drive new ideas, but also have pragmatic approach to development options, technology selection and regulatory posture
- Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong experience in safety and environmental knowledge and site presence.
- Candidate should have solid understanding of integration and partnering for Pharmaceutical development/CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas
- Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaboration skills.
- A strong track record of publications in parenteral drug product development and/or delivery
- Demonstrated ability to lead cross-functional teams with proven talent development skillsets.
- Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings for biopharmaceuticals or vaccine products.
Preferred Experience and Skills:
- Expertise in biological and/or vaccine clinical and commercial manufacturing would be ideal
- Strong process development (including upstream and downstream) and technology transfer experience is sought.
- Knowledgeable of the Capital Process having participated on a large capital project team
- Exposure to project / engineering work process and deliverables (e.g. equipment fabrication, FAT, SAT, Validation etc.)
- Experience in regulatory compliance expectations across all phases of product development to commercialization.
- Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).
- Experience in budget planning & management, establishing development strategies, and managing scientific staff from a budgetary and personnel decisions standpoint.
- Highly motivated, flexible, a change agent, and ability to work in a fast-paced environment.
- Willing to implement novel and innovative technologies into vaccine programs. Ability to provide novel and creative solutions to challenges and pinch points in vaccine development. Encourages innovative thinking / risk-taking and eliminates obstacles / barriers to implement change
- Ability to present clear and compelling quality and business cases. Ability to engage and align other stakeholders outside the project team.
- Ability to apply and promote a growth mindset with teams and partnerships
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
EEOC GINA Supplement
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:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/21/2024
*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:R320242