Senior Scientist, Downstream Process Development and Commercialization

Job Description

Join Our Team as a Senior Scientist in Downstream Purification!

Are you ready to make a significant impact in the world of biopharmaceuticals AtOur Company we are at the forefront of innovation in the Manufacturing Division specifically within theBiologics Drug Substance Commercialization (BDSC)team. OurDownstream Purificationdepartment is dedicated to leading the charge in downstream processing for late-stage pipeline and commercial drug substance manufacturing focusing on life-saving therapeutics.

What Youll Do:

As a Senior Scientist you will play a pivotal role in shaping the future of biopharmaceutical manufacturing. Working under the guidance of our technical leader in downstream processing you will collaborate with both internal and external partners to support our late-stage programs. Your scientific expertise and experimental skills will be crucial in driving our mission forward.

Key Responsibilities:

• Innovate and Collaborate:Join dynamic teams focused on late-stage commercial process development process characterization and technology transfer all aimed at achieving product licensure and commercialization.
• Lead Laboratory Studies:Conduct laboratory-scale studies that support commercial process validation and characterization whether in-house or through external partnerships.
• Drive Technical Excellence:Provide technical leadership in designing experiments analyzing data and executing or managing laboratory activities.
• Expand Your Expertise:While your primary focus will be on downstream processing you will gain insights into various aspects of drug substance manufacturing including cell culture and analytical methods.
• Engage with Partners:Actively interact with internal and external stakeholders representing your functional area on cross-functional teams.
• Document Your Impact:Author essential regulatory and technical documentation ensuring that all processes and products meet our high standards.

What You Bring:

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) in Biological Sciences Chemical Engineering Biological Engineering or Chemistry with six (6) years of required experience. OR
• Master of Science (MS) in Biological Sciences Chemical Engineering Biological Engineering or Chemistry with four (4) years of required experience. OR
• PhD in Biological Sciences Chemical Engineering Biological Engineering or Chemistry with no required experience (chromatography and filtration experience preferred).

Required Skills and Experience:

• A solid technical background in the purification of biological molecules including hands-on experience with chromatography and filtration systems.
• Strong foundational knowledge in downstream processing of biologics.
• Exceptional communication skills with the ability to articulate complex process science concepts to drive decision-making in a multidisciplinary team environment.

Preferred Skills and Experience:

• In-depth experience with downstream purification techniques particularly preparative chromatography tangential flow filtration and virus-retaining filtration.
• Familiarity with technology transfer and scaling processes for biologics manufacturing.
• Experience in late-stage process development including viral clearance studies and regulatory submissions.
• Proficiency in statistical methods for design of experiments (DOE) and data analysis using tools like JMP.
• Understanding of analytical methods for characterizing biologics and knowledge of US/EU regulatory requirements and cGMPs is a plus.

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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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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 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 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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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