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Contract Gmp Manufacturing Jobs in Michigan (NOW HIRING)

Celldex Therapeutics

... DS) GMP external clinical and commercial manufacturing, oversee operations on-site at the Contract Development Manufacturing Organization (CDMO), support process technology transfer, process ...

Posted today

Logoplaste

Be Seen First

Plant Manager- Manufacturing

Mecosta, MI · On-site

$120K - $140K/yr

... contract negotiations. * Implement cost-effective systems of control over capital, operating ... Comply with all company safety policies and procedures, as well as maintain good housekeeping, GMP ...

Merit Manufacturing

Product Inspector

Warren, MI · On-site

$38K - $48K/yr

Build a career in contract manufacturing by learning equipment, quality control, and how to manage ... Follow GMP documentation guidelines * Assist Production as needed during Production This is a ...

Roskam Baking Company

Production Technician

Kentwood, MI · On-site

$15.75 - $19.75/hr

... contract manufacturer that partners with world-renowned food brands, retailers, and food service ... The Production Technician will be trained in GMP principles and will be responsible for maintaining ...

Roskam Baking Company

Production Technician

Kentwood, MI · On-site

$15.75 - $19.75/hr

... contract manufacturer that partners with world-renowned food brands, retailers, and food service ... The Production Technician will be trained in GMP principles and will be responsible for maintaining ...

Roskam Baking Company

Production Technician

Kentwood, MI · On-site

$15.75 - $19.75/hr

... contract manufacturer that partners with world-renowned food brands, retailers, and food service ... The Production Technician will be trained in GMP principles and will be responsible for maintaining ...

Roskam Baking Company

Machine Operator

Kentwood, MI · On-site

$15.50 - $18.50/hr

... contract manufacturer that partners with world-renowned food brands, retailers, and food service ... Follow all elements of Food Safety to ensure GMP, HACCP and proper packaging standards are met.

Roskam Baking Company

Production Technician

Kentwood, MI

$15.75 - $19.75/hr

... contract manufacturer that partners with world-renowned food brands, retailers, and food service ... The Production Technician will be trained in GMP principles and will be responsible for maintaining ...

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Contract Gmp Manufacturing information

What is Contract GMP Manufacturing?

Contract GMP (Good Manufacturing Practice) Manufacturing refers to outsourcing the production of pharmaceutical, biotechnology, or medical device products to specialized manufacturers who comply with GMP regulations. These contract manufacturers have the facilities, expertise, and quality systems required to ensure products are consistently produced and controlled according to regulatory standards. Companies often use contract GMP manufacturers to save costs, access specialized technology, or scale production quickly without investing in their own manufacturing infrastructure.

What are the key skills and qualifications needed to thrive as a Contract GMP Manufacturing professional?

Success in Contract GMP Manufacturing requires a solid background in bioprocessing or pharmaceutical manufacturing, a strong understanding of Good Manufacturing Practices (GMP), and typically a degree in a relevant scientific or engineering field. Familiarity with industry-standard quality management systems, batch record documentation, and equipment validation, as well as certifications like Six Sigma or cGMP training, are highly valued. Attention to detail, problem-solving skills, and effective communication help professionals navigate regulatory requirements and collaborate with clients and cross-functional teams. These competencies ensure product quality, regulatory compliance, and client satisfaction in a highly regulated manufacturing environment.

What are some common challenges faced in a Contract GMP Manufacturing role, and how can they be addressed?

Professionals in Contract GMP Manufacturing often face challenges such as adapting to diverse client requirements, ensuring strict regulatory compliance, and managing tight production timelines. Successful candidates should be comfortable working in fast-paced environments where priorities may shift quickly. Collaboration with cross-functional teams—like Quality Assurance, Regulatory Affairs, and clients—is essential to navigate these challenges. Maintaining clear communication and robust documentation practices helps ensure both compliance and client satisfaction.

What is the difference between Contract Gmp Manufacturing vs Quality Control Analyst?

AspectContract Gmp ManufacturingQuality Control Analyst
CertificationsGMP training, relevant manufacturing certificationsGMP, QC certifications, lab skills
Work EnvironmentManufacturing facilities, production linesLaboratories, testing environments
Industry UsagePharmaceutical manufacturing, biotechQuality assurance, testing labs

Contract Gmp Manufacturing involves producing pharmaceutical products under GMP standards, focusing on manufacturing processes. Quality Control Analysts test and verify product quality in labs. While both roles require GMP knowledge, manufacturing roles emphasize production, whereas QC analysts focus on testing and quality assurance.

What are the most commonly searched types of Gmp Manufacturing jobs in Michigan?

The most popular types of Gmp Manufacturing jobs in Michigan are:

What are popular job titles related to Contract Gmp Manufacturing jobs in Michigan?

For Contract Gmp Manufacturing jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Contract Gmp Manufacturing jobs in Michigan look for?

The top searched job categories for Contract Gmp Manufacturing jobs in Michigan are:

What cities in Michigan are hiring for Contract Gmp Manufacturing jobs?

Cities in Michigan with the most Contract Gmp Manufacturing job openings:

Contract Gmp Manufacturing jobs near you

Manager, Biologics Drug Substance External Manufacturing

Celldex Therapeutics

On-site

Full-time

Medical, Retirement, PTO

Posted 23 hours ago

Posted today

Job description

Overview

The Manager, Biologics Drug Substance External Manufacturing works cross-functionally with internal and external teams to support drug substance (DS) GMP external clinical and commercial manufacturing, oversee operations on-site at the Contract Development Manufacturing Organization (CDMO), support process technology transfer, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.

Responsibilities
  • Support GMP external manufacturing of clinical or commercial biologics DS.
  • Serve as a person-in-plant (PIP) to monitor manufacturing batches (upstream/downstream processing) operations at the CDMO site.
  • Review Contract Development and Manufacturing Organization (CDMO) batch records, protocols, and reports. Lead/ support troubleshooting, process risk analysis and manufacturing investigations.
  • Support process validation for commercialization of biologics drug substance.
  • Support Continuous Process Verification (CPV) program for commercial biologics manufacturing.
  • Support technology transfer of pipeline drug candidates to external CDMOs.
  • Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.
Qualifications
  • Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
  • 4+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
  • 2+ years of experience in managing or working with biologics CDMOs.
  • 2+ years of experience in working with late-phase biologics programs
  • Interpersonal skills to effectively manage internal and external communications.
  • Able to travel 30 % of time.
  • Proficient in the use MS Outlook, Word, Excel, Project, PowerPoint, Visio.
Compensation Statement The expected base salary for this position is: $ to $ . We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

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