Job DescriptionOur 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 a person 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 our company's Research and Development 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, individual will lead downstream process development of recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will serve as the lead for a group(s) of downstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine production including the manufacture of cGMP clinical bulks and tech transfer processes 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 may also be responsible for the leadership of cross-functional technical working groups. In this role, the individual may function as an individual contributor or technical/scientific lead of a process development team.Primary responsibilities include, but are not limited to:
People manager of a team (5 scientists)
Serve as a technical lead in the areas of vaccines and advanced biotechnologies process development, characterization, and technology transfer.
Drive the development of new principles, concepts, and methods to enable process development, scale-up of processes to pilot scale, and technology transfer to manufacturing scale.
Develop robust and scalable manufacturing processes while minimizing time to file and launch.
Identify and lead strategic initiatives and innovation in the area of vaccine and advanced biotechnology process development.
Represent functional area in cross-functional teams engaged in advancing novel vaccine and advanced biotechnology development.
Actively network with both internal and external counterparts (i.e. biopharma industry, academia).
Continuously monitor scientific and regulatory landscape and actively present (premier conferences), publish (peer-reviewed journals), and patent
Author required regulatory and technical documentation. Ensures that process/product are developed and documented according to our company's standard practices.
Provide mentorship, technical oversight and strategic guidance to direct reports.
Handle multiple priorities and balance work to achieve business goals.
The successful candidate will be expected to demonstrate the ability to communicate results of work in both verbal and written formats. They are also 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 comply with all required training and maintain a focused attention on 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. This position may require occasional off-hour and weekend work.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 (16) years of experience in biotechnology related position
For MS, at least ten (14) years of experience in biotechnology related position
For PhD, at least eight (10) years of experience in biotechnology related position
Must have strong scientific understanding of chromatography, membrane filtration operations, centrifugation techniques, analytical process monitoring, and experience with practical hands-on process development.
Excellent scientific understanding of a variety of downstream techniques
At least 6 years of hands-on experience in protein sub-unit and/or microbial-derived product purification production processes
Working knowledge of upstream operations
Prior experience of statistical design of experiments
Strong understanding of or experience in technology transfer and cGMP manufacturing at clinical or commercial scale
Experience in mentoring/managing teams of scientists/engineers
The successful candidate will have a strong background in downstream development with practical experience and a command of modern chromatography, membrane, and centrifugation technologies. Individual will have good familiarity with chemical engineering principles and an understanding of the regulatory guidelines governing cGMP manufacture.Preferred Experience and Skills:
Prior experience in process scale-up
Strong foundation in chemical engineering principles and their application to downstream unit operations
Prior experience in the development of lab, pilot, and commercial scale purification processes
Prior experience with purification techniques used for the isolation of proteins, polysaccharides, membrane vesicles, viruses and/or virus-like particles
Prior experience with common analytical methods such as SDS-PAGE, DLS, UV-VIS, SEC, and HPLC & UPLC
Prior experience with implementing PAT and/or applying “-omics” approaches to solve downstream bioprocess challenges
Experience in authoring and reviewing CMC regulatory documentation
People manager and/or technical lead of a process development team
Project management experience including participation and/or 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.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: R284135
