Since 2012, Jim Champlin has been working in Maine Standards Company. Jim is a qualified Manager, Quality Assurance and Regulatory Affairs with over 36 years of work experience. According to Jim's CV and work profile, this professional has worked at more than nine places with diverse backgrounds and got various skills. Jim attended school at the Northeastern University from 1977 to 1978. Jim Champlin can be found in Portland, Maine – where this expert currently lives. You can search for Jim's phone number and email. We can also provide you with additional contact information upon request.
Name variants:
James Champlin
Last updated May 26, 2024
Contact Information
Workplace
Manager, Quality Assurance and Regulatory Affairs
Windham, ME
Industry
Commercial Physical Research, Commercial Physical Research Mfg Diagnostic Substances, Surgical & Medical Instrument Mfg
Colleagues
Work History
Regulatory Affairs Manager
Cambridge, Massachusetts
Responsible for CMC regulatory affairs activities focusing on antibody production, purification and conjugation. Created and supported product master files with FDA (CBER). Reviewed interna...
Jul 2012 — Nov 2012
Manager, RA&QA
Responsible for domestic and international Regulatory Affairs and Quality Assurance activities for immunological reagent company with two facility locations.
Implemented and maintained emplo...
1998 — Jan 2012
Manager RA &QA
Responsible for regulatory affairs and quality assurance activities for immunological reagent (flow cytometry, immuno-histochemistry, immunoassay) company based in Marseille, France. Conduc...
Oct 1994 — Jun 1998
Manager, RA & QA
Responsible for regulatory affairs and quality assurance activities for analytical instrument and chromatography gel company with four facilities.
Created product/process validation protocol...
Jun 1993 — Sep 1994
Manager, RA & QA
Responsible for regulatory affairs and quality assurance activties for biomedical division.
Implemented product qualification systems and initiated ISO 9001 certification program. Compiled ...
Jun 1991 — Jun 1993
Director, RA&QA
Responsible for regulatory affairs and quality assurance activties for IVD company.
In Vitro diagnostic immunoassays and cell culture accessories. In charge of interfacing with the FDA (CD...
Jan 1983 — Jun 1991
Manager, Regulatory Affairs
Responsible for regulatory affairs activities for medical device company with four locations. Medical device plastic disposables and large volume parenterals. Responsible for maintaining l...
Sep 1980 — Dec 1982
Regulatory Affairs Coordinator
Responsible for regulatory affairs activties associated with radiopharmaceutical company. Diagnostic radiopharmaceuticals and radioimmunoassays.
Prepared IND/NDA filings to the FDA (CDER).
Aug 1975 — Aug 1980
Education
1977 — 1978
1971 — 1975
Occupations
Quality Assurance Professional
Executive
Manager
IT Professional
Software Tester
Scientist
Biotechnology Professional
Inspector
Operations Manager
Computer Specialist
Biologist
Biological Scientist
FAQs about Jim Champlin
What is the main profession of Jim Champlin?
This professional's job is Regulatory Affairs & Quality Assurance Professional
What jobs is Jim a professional at?
The expert is a professional Quality Assurance Professional jobs.
Where does Jim Champlin live?
The expert lives in Portland, Maine.
Where did Jim Champlin work?
Jim worked at Maine Standards Company LLC, Miltenyi Biotec.
What education does Jim Champlin have?
Jim studied at the Northeastern University from 1977 to 1978.
Are there any special awards, that Jim Champlin ever received?
Jim received awards and these awards are: RAC certified Lean Six Sigma Certified ISO 13485 Certified Auditor.
What languages does Jim Champlin speak?
Jim Champlin speaks French.
Are there any industries, that Jim Champlin works in?
Jim Champlin works in Biotechnology industry.