Associate Principal Scientist Upstream Development
Associate Principal Scientist Upstream Development
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
Job Description:
The Biologics Process Research & Development organization within our companys Research Laboratories is responsible for developing the drug substance manufacturing processes for our companys biologics pipeline. We work closely with colleagues in Discovery Preclinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new manufacturing technologies. We work with our partners in our companys Manufacturing Division to commercialize and launch new products.
We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist. Applicant must have effective organizational and multitasking skills demonstrated excellent scientific leadership in Upstream process development and superior written and oral communications abilities. Evidence of strong crossfunctional collaboration significant external presence with scientific excellence and interest and abilities for mentoring junior staff are also expected.
In this role the successful candidate will work closely with a highly motivated team of Scientists and Engineers in the Upstream Process Development area and contribute to CMC development of our companys pipeline playing an active role in the design development and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. She/He will also participate in developing and refining strategies related to nextgeneration processes through technology development initiatives for assets in early and latestage clinical development.
Responsibilities include but are not limited to:
Participates in and/or leads upstream process development of firstinhuman and commercial processes by efficiently developing high yield robust and scalable cell culture processes.
Responsible for process development process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the companys pipeline.
Partner with colleagues in Discovery Cell Line Downstream Process Development Analytical Sciences and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve quality by design targets with robust control strategies.
Advancing the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
Collaborate with academia industry partners and vendors to drive development innovation and adoption of new process technologies.
Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.
MINIMUM EDUCATION REQUIREMENTS:
Ph.D. with 3 years experience or masters with 7 years experience in chemical engineering Bioengineering Biological Engineering or a related field
REQUIRED EXPERIENCE AND SKILLS:
Technical background and handson experience with mammalian cell culture and fedbatch processes to produce recombinant proteins.
Scientific understanding and working knowledge of CHO cell biology metabolism cell culture media and engineering principles for large scale recombinant protein production systems.
Working knowledge of statistical methods (design of experiment multivariate data analysis) and tools (SIMCA JMP etc..
Understanding of cell culture bioreactors including microbioreactors benchscale and pilotscale bioreactors and bioreactor scaleup principles from laboratory to large scale.
Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
Ability to direct the planning analysis and documentation of all stages of cell culture process development.
Plan execute analyze and communicate complex and critical data in a highly organized manner.
Excellent verbal written communication and interpersonal skills.
Ability to work effectively in crossfunctional and matrixed team environment; collaborate with both internal and external partners including vendors.
Demonstrated ability for taking initiative creativity and innovation in problem solving.
Productivity and efficiency working in the laboratory.
Ability to deliver complex objective under aggressive timelines.
PREFERRED EXPERIENCE AND SKILLS:
Experience with cell culture media development.
Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
Experience with stateoftheart cell culture processes including intensified inoculum/fedbatch and perfusion process development.
Background in data science approaches related to cell culture and predictive modeling e.g. metabolic flux (MFA) analysis omics machine learning; computational fluid dynamics and experience integrating PAT efforts.
Experience with latestage commercial process development technology transfer scaledown model qualification and process characterization.
Knowledge of biologics CMC development cycle and scaleup/down in addition to tech transfer to GMP manufacturing site.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$139600.00 $219700.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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
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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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/2/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
