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Project Manager Cdmo Jobs in Michigan (NOW HIRING)

Niowave Inc.

MS&T Accelerator Specialist

Lansing, MI · On-site

Experience operating in a cGMP CDMO or Finished Drug environment * Formal training/application of Project Management Other things to know... * Full-time position * Niowave's standard operating hours ...

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Project Manager Cdmo information

What is a Project Manager CDMO?

A Project Manager CDMO (Contract Development and Manufacturing Organization) is responsible for overseeing pharmaceutical or biotech projects outsourced to CDMOs. They coordinate between clients and internal teams to ensure timely delivery, quality, and compliance with regulatory standards. Their role includes managing project timelines, budgets, and resources, as well as communicating progress and addressing issues that may arise during drug development and manufacturing processes.

What are the key skills and qualifications needed to thrive as a Project Manager in a CDMO (Contract Development and Manufacturing Organization), and why are they important?

To excel as a Project Manager in a CDMO, you need a strong background in project management, life sciences, and regulatory compliance, often supported by a relevant degree and PMP certification. Familiarity with project management software (like MS Project or Smartsheet), quality management systems, and industry-specific regulations such as GMP are typically required. Outstanding organizational, communication, and stakeholder management skills help you effectively coordinate cross-functional teams and client expectations. These competencies are vital for delivering complex projects on time and within budget while maintaining regulatory standards and client satisfaction.

How does a Project Manager at a CDMO typically coordinate between clients and internal teams throughout a project lifecycle?

A Project Manager at a Contract Development and Manufacturing Organization (CDMO) acts as the central point of contact for clients and internal teams, ensuring clear communication and alignment of project goals. They regularly facilitate meetings, track project milestones, and proactively address potential issues or changes in scope. This involves close collaboration with departments such as R&D, manufacturing, quality assurance, and regulatory affairs to meet client expectations and project timelines. Effective project managers also document progress and maintain transparent reporting to both clients and internal stakeholders.
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Infographic showing various Project Manager Cdmo job openings in Michigan as of June 2026, with employment types broken down into 3% As Needed, 1% Full Time, 95% Part Time, and 1% Nights. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution.
Regulatory Affairs Professional/Sr. Regulatory Affairs Professional

Regulatory Affairs Professional/Sr. Regulatory Affairs Professional

Grand River Aseptic Manufacturing

Grand Rapids, MI • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 8 days ago

Job description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!
Overview of this Position:
The Regulatory Affairs Specialist oversees regulatory affairs activities for the contract development and manufacturing organization (CDMO) where GRAM's clients are the sponsors, application- and license- holders for sterile injectable products, from clinical through commercial phases. Manages a broad spectrum of projects to support the regulatory needs of GRAM and GRAM's clients. This position interacts with all internal departments within GRAM and with external clients, suppliers, contractors, and regulatory agencies. This position does not oversee direct reports. This is not a remote role.
Non-Negotiable Requirements:
  • Bachelor's degree in Life Sciences or a related field
  • 10+ years of experience in the pharmaceutical industry and 6 years of hands-on experience in Regulatory Affairs with increasing responsibilities.
  • Working knowledge of regulatory requirements (e.g., FDA/ICH/EUGMP regulations, GDUFA) and familiarity with regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA,EU variation review responses, post-approval supplements and pre-submission meeting packages.
  • Knowledgeable in regulatory science and submission data requirements of all phases of product development for sterile parenteral products.
  • Knowledge of cGMP, ICH, and USP regulations or guidelines.
  • Excellent technical writing skills.
  • Prior experience preparing FDA correspondence.

Preferred Requirements:
  • Candidate with prior or current roles within or working closely with a CMO/CDMO preferred.
  • Experience with international pharmaceutical regulations desired (TGA, ANVISA, JP, EMA, Health Canada, etc.).
  • Regulatory Affairs Certification (RAC).
  • Member of pharmaceutical trade associations such as RAPS, ISPE, PDA, etc.
  • Advanced knowledge of quality standards (FDA 21 CFR 11, 210, 211, 600; EudraLex vol 4, Annex 1, PIC/S) statistical analysis, root cause analysis, quality measurement, CAPA, SPC, FMEA.

Responsibilities Include (but are not limited to):
  • Maintain current knowledge of all relevant regulations (21CFR Parts 11, 210, 211, 600, 820 and applicable guidance documents, EudraLex Volume 4) while also monitoring any changes that occur which may impact products manufactured as well as access and communicate regulatory requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
  • Provide regulatory CMC support to GRAM clients, including providing documents for filings and review of client submissions on behalf of GRAM; ensure submissions are aligned with GRAM's supply agreements (e.g. clinical, commercial, markets).
  • Submit and maintain letters of authorizations (LOA) for GRAM's clients to reference a Type V Drug Master File in submissions.
  • Maintain and manage existing FDA establishment registrations and product listings (NDC, SPL), filing/obtaining new registrations as required.
  • Generate and maintain NDC codes for GRAM's FDA approved commercial products for Cares Act Reporting.
  • Facilitate GRAM Client quality agreements, providing input and ensuring alignment with regulatory requirements.
  • Responsible for submitting annual GDUFA self-identification(s) to FDA.
  • Maintenance of GRAM's Type V Drug Master File (sterile processing facility), including amendments, annual reports.
  • Maintenance of Site Master Files for GRAM's facilities.
  • Support BD due-diligence evaluation of new business opportunities and provide meaningful contributions to the new-business selection process.
  • Develop and maintain SOPs, work instructions, forms and other documentation and training materials related to Regulatory Affairs.
  • Perform Regulatory Assessments for GRAM's holistic change control process.
  • Write, revise, review relevant departmental SOPs, SWIs and associated documents.
  • Support Agency, customer and vendor audits as needed.

Full job description available during formal interview process.
What Sets GRAM Apart from Other Employers:
MEDICAL BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
PAY: Depends on Experience and is discussed during the interview process.
If you meet the required criteria listed above, GRAM welcomes you to apply today!

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