Associate Principal Scientist Downstream Process Development
Associate Principal Scientist Downstream Process 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 the development and implementation of new manufacturing technologies. We work with our partners in the companys Manufacturing Division to commercialize and launch new products.
We are seeking a highly motivated and experienced individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist. In this role you will work with a highly collaborative team of Scientists and Engineers to design and develop downstream purification processes in support of early and latestage biological products. The scope and activities include designing and optimization of downstream unit operations such as cell harvest filtration chromatography viral clearance precipitation crystallization and continuous processing for batch and intensified/continuous bioprocesses. The role will also include strategic Applicants should have effective organizational and multitasking skills and strong communication skills both verbal and presentation of data is required. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems are distinguishing. Evidence of strong crossfunctional collaboration experience successfully mentoring junior scientists leading projects and an external presence through scientific excellence are expected.
JOB RESPONSIBILITIES:
The successful candidate will contribute to CMC development of our companys pipeline playing an active role in development of downstream processes and transfer to clinical and commercial manufacturing sites. They will also develop strategies for process and pipelinefacing innovation.
Responsibilities include:
Leading biologic downstream process development for firstinhuman and commercial processes by efficiently developing high yield robust and scalable processes. Independently designing and conducting experiments using relevant operational parameters and analytical inputs.
Providing technical supervision for process development and characterization
Collaborate with upstream process development Biologics Analytical R&D and other crossfunctional teams in both Research and Manufacturing to advance biologics pipeline.
Advancing downstream platform process technical strategy and championing creative process improvement initiatives
Assessing new technologies sciences and industry strategies and relevance to our company
Collaborating with academia industry partners and vendors to drive development innovation and adoption of new process technologies
Keeping up to date with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies
Mentoring junior scientists
EDUCATION REQUIREMENTS:
Ph.D. with 3 years of industry experience or Master with 6 years industry experience or BS with 8 years in industry experience in Chemical Engineering Biochemical engineering or a related field
REQUIRED SKILLS:
Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.
Scientific understanding of the engineering principles for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.
Ability to direct the planning analysis and documentation of all stages of downstream process development.
Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors
Knowledge of biologics CMC development cycle
Demonstrated ability for taking initiative creativity and innovation in problem solving
PREFERRED SKILLS:
Experience with high throughput experimentation using automation platforms such as TECAN
Experience using and/or programming process control systems such as DeltaV and PCS 7
Experience with integrated and continuous processing and equipment including multicolumn chromatography systems (BioSMB PCC or similar)
Background or experience in data science approaches related to downstream processes and predictive modeling (multivariate data analysis machine learning/artificial intelligence leveraging PAT)
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
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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:
05/9/2025*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
