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Associate Scientist, Downstream Bioprocess Drug Substance Commercialization

AT Merck
Merck

Associate Scientist, Downstream Bioprocess Drug Substance Commercialization

Spring House, PA

Job Description

Position Description:

As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioseparation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics.

For pipeline programs, BDSC supports various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions. For commercial programs, BDSC supports process improvement, post approval next generation process development and characterization, manufacturing investigation, process validation, and regulatory submission authoring.

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Under the general scientific and administrative direction of the technical leader in downstream, this individual will support late stage and commercial large molecule programs within BDSC. This individual will demonstrate scientific and experimental skills focusing on downstream processing.

Primary Responsibilities

  • Responsible for performing and executing laboratory experiments and investigations for the purposes of generating new data and knowledge.


  • Documents lab activities, findings and conclusions in lab notebook and scientific reports, and presents knowledge at appropriate forums.


  • Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations. May authors experimental protocols.


  • As an individual contributor, will be concerned with clearly identifiable elements or functions within a larger project team.


  • 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.


  • GMP responsibilities include authoring technical and regulatory documents.

Qualifications:

Education Minimum Requirement:

  • Bachelor's Degree or higher in Chemical Engineering, Biological Engineering, Chemistry, Biology

Required Experience and Skills:

  • Relevant academic, internship, co-op, or professional experience in a laboratory setting.

Preferred Experience and Skills:

  • Theoretical understanding or practical experience in protein biochemistry and/or separation sciences as it relates to purification of biological molecules.
  • Excellent oral and written communication skills. Good working knowledge of general office software (e.g., Microsoft Word, PowerPoint, etc.)
  • Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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 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".

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

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/25/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R317815

Client-provided location(s): West Point, PA, USA
Job ID: Merck-1054242452
Employment Type: Full Time