Job DescriptionApplications are sought for an opportunity in the Vaccines & Advanced Biotechnologies - Process Research & Development (VAX PR&D) department, which is part of our Company's Research Labs division. The individual will support our Company’s discovery & development efforts for Vaccine programs at West Point, PA.Under the direction of the Sr. Director, this role will lead upstream and/or downstream process development efforts for recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will serve as the technical lead and people manager for a group of upstream and/or downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine 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), and commercialization (BDSC).Primary responsibilities include, but are not limited to:
Technical lead and people manager of a team (10-15 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 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 team.Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. 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 twelve (12) years of experience in biotechnology related position
For MS, at least ten (10) years of experience in biotechnology related position
For PhD, at least eight (8) years of experience in biotechnology related position
Must have strong scientific understanding of process development principles.
Excellent scientific understanding of a variety of upstream and/or downstream techniques
At least 4 years of hands-on experience in protein sub-unit and/or microbial-derived product process development.
Prior experience of statistical design of experiments
Strong understanding and experience in technology transfer and cGMP manufacturing at 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 both upstream and downstream process development
Prior experience in protein subunit and/or yeast-based vaccines
Strong foundation in chemical engineering principles and their application bioprocess unit operations
Prior experience in the development of lab, pilot, and commercial scale processes
Prior experience in implementing PAT and/or “-omics” approaches to solve bioprocess challenges
Project management experience including participation or preferably leadership of technical working groups
NOTICE FOR INTERNAL APPLICANTSIn 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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 CarefullyMerck & 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:RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Requisition ID: R284132
