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Job Description

Position Description:

Associate Principal Scientist, Bioconjugation and Chemistry Commercialization

Contributes to commercialization activities of late stage pipeline and /or commercial manufacturing support for biologically derived drug substances (e.g., therapeutic proteins or vaccines) generated from bioconjugation processes as part of the Bioconjugation and Chemistry Commercialization team.

For late stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. 

Responsible for but not limited to:

  • Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance processes. 
  • Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.
  • Leads or coordinates cross-functional project/program teams from technology transfer to filing of commercial process with regulatory agencies.
  • Solves technical and non-technical problems throughout the life of the project, resolves problems during the design and planning phases whenever possible.
  • Ensures project results meet requirements regarding technical quality, reliability, schedule and cost.
  • Provides timely and accurate information and status updates to project sponsors, end users, functional leaders and management.
  • Participates in budget development and evaluating how project plan changes impact cost and schedule.
  • May oversee and coordinate work performed by others.
  • This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing.
  • This role may also require approximately 10% of time spent on domestic or international travel.

Position Qualifications:

Education Minimum Requirement:

  • Bachelor's Degree in Engineering, Science or related field with a minimum of 10 years of relevant experience; or
  • Master's Degree with a minimum of 8 years of relevant experience; or
  • Doctoral Degree (Ph.D) with 4 years of experience.

Required Experience and Skills:

  • Experience with large molecule manufacturing processes
  • Experience designing process development experiments using risk-based methodology or similar
  • Experience with on-the-floor GMP manufacturing support
  • Experience authoring regulatory submissions such as BLAs, INDs, or other regulatory source documentation.
  • Ability to collaborate well with multidisciplinary teams
  • Ability to drive deliverables to completion and achieve required project timelines
  • Possesses outstanding communication skills
  • Ability to coach others and manage medium and large multidisciplinary teams effectively

Preferred Experience and Skills:

  • Experience with bioconjugation processes
  • Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites
  • Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar

NOTICE FOR INTERNAL APPLICANTS

In 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

Current Contingent Workers apply HERE

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 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:

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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.

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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, 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 Carefully 

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. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

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Confirmed an hour ago. Posted a day ago.

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