MSAT Engineer/Specialist

Kelly Services

Bristol Township (Bucks County)

On-site

USD 55,000 - 72,000

Part time

6 days ago
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Benefits offered by this job

Medical
Dental
Vision
Telemedicine
Term life
Whole life
Accident insurance
Critical illness
Legal plan
Short-term disability
Retirement savings plan
Service bonus and holidays
Transit spending account
Paid sick leave

Job summary

Kelly Science & Clinical in Bristol, PA seeks an MSAT Engineer/Specialist for a contract-to-hire role overseeing technology transfer of bioconjugation processes (ADCs/AOCs) into cGMP manufacturing.

You will partner with development and manufacturing teams, author batch records, maintain documentation, support investigations, and drive continuous improvement and training.

Qualifications

  • Bachelor’s degree in scientific or engineering discipline; 3–5 years in biopharma MSAT or technical operations focusing on ADC/AOC processes.
  • Proven track record in development and clinical-stage support, including batch record authorship and process documentation.
  • GMP operations experience, manufacturing floor support, deviation resolution, and change control.
  • Hands-on experience with conjugation chemistries, TFF, Protein A, IEX, and HIC.

Responsibilities

  • Provide technical leadership for technology transfer into cGMP manufacturing, including facility fit assessments, scale up planning, and risk assessments.
  • Lead transfer of bioconjugation processes into cGMP manufacturing from internal teams and external development partners.
  • Author and revise batch records and master batch production documents to support cGMP clinical manufacturing.
  • Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P&IDs, as required to support execution and readiness.
  • Lead or support process investigations, deviations, CAPAs, and root cause analysis related to cGMP manufacturing.
  • Champion process safety by translating OEB controls into practical manufacturing requirements for equipment, PPE, waste, and cleaning.
  • Provide in-person and real-time manufacturing production support required for project success.
  • Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
  • Technical training and knowledge management. Develop training content for new processes, new equipment, and new batch record revisions. Maintain a living knowledge package per program, including lessons learned, known failure modes, and standard responses.
  • Adhere to all GLP, and cGMP requirements as well as company policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
  • Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.

Skills

ADC/AOC processes
Bioconjugation expertise
Process transfer leadership

Education

Bachelor’s degree in science/engineering

Tools

Conjugation chemistries
TFF
Protein A
IEX
HIC

Job description

Kelly® Science & Clinical is seeking an MSAT Engineer/Specialist for a contract to hire position at a pharmaceutical leader in Bristol, PA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career.

Compensation: $40.00-52.00

Schedule: M-F, 1 st shift

Duration: Contract to hire

SUMMARY

We are seeking an experienced and highly skilled engineer with expertise in bioconjugation processes, including Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs), to support development-to-clinical cGMP manufacturing operations. You will serve as the MSAT technical bridge between process development and manufacturing, ensuring successful technology transfer, manufacturing readiness, and sustained process robustness for highly potent and complex biologic drug conjugates across the product lifecycle.

RESPONSIBILITIES
  • Provide technical leadership for technology transfer from internal or external process development teams into cGMP manufacturing, including facility fit assessments, scale up planning, and risk assessments.
  • Lead transfer of bioconjugation processes into cGMP manufacturing from internal teams and external development partners.
  • Author and revise batch records and master batch production documents to support cGMP clinical manufacturing.
  • Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P&IDs, as required to support execution and readiness.
  • Lead or support process investigations, deviations, CAPAs, and root cause analysis related to cGMP manufacturing.
  • Champion process safety by translating OEB controls into practical manufacturing requirements for equipment, PPE, waste, and cleaning.
  • Provide in-person and real-time manufacturing production support required for project success.
  • Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
  • Technical training and knowledge management. Develop training content for new processes, new equipment, and new batch record revisions. Maintain a living knowledge package per program, including lessons learned, known failure modes, and standard responses.
  • Adhere to all GLP, and cGMP requirements as well as company policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
  • Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.
QUALIFICATIONS
  • Minimum Bachelor’s degree in scientific or engineering discipline or equivalent with 3-5 years of experience in biopharma MSAT or technical operations with a focus on ADC and/or AOC processes.
  • Proven track record in both development and clinical-stage support, including batch record authorship and process documentation.
  • Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control.
  • Hands-on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC).
  • Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel
  • Familiarity with semi/fully automated manufacturing equipment
  • Proven ability to troubleshoot bioprocess operations and equipment.
  • Understanding of relevant analytical, processing, and scale-up calculations.
  • Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools.
  • Strong interpersonal and communication skills, with the ability to interface effectively with cross-functional teams and clients

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

  • medical
  • dental
  • vision
  • telemedicine
  • term life
  • whole life
  • accident insurance
  • critical illness
  • a legal plan
  • short-term disability
  • retirement savings plan
  • service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
  • transit spending account
  • paid sick leave under the applicable state or local plan

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en).

Kelly Services is proud to be an Equal Employment Opportunity and Affluent Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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