Method Development & Validation Manager

Employer
Bachem
Location
Torrance, CA
Posted
Jul 30, 2021
Ref
698674001
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

The Manager, Method Development and Validation (MDV) fulfills a critical role in active pharmaceutical ingredient development and manufacturing operations. This individual manages development and validation of Analytical Methods for early and late stage Active Pharmaceutical Ingredients within the QC department in compliance with current GMP rules and regulations.

Your Tasks:

  • Maintain and coordinate the operation of the MDV department in coordination with client/company/regulatory goals. This includes prioritizing work for development/validation with the MDV personnel on a regular basis
  • Review laboratory notebooks, raw data, development/summary reports, protocols and operational SOPs as necessary
  • Oversee the execution of method development and validation activities and ensure adherence to GMPs and any other regulatory guidelines including ICH
  • Meet with internal and external customers to ensure their goals are met and the methods and data are delivered to them on mutually agreed upon turnaround time. Ensure information is suitable for their intended use and received in a timely fashion. Keep open channels of communication with the customer and provide status updates as necessary
  • Author and/or review validation protocols and reports and method development reports, as necessary. Write/review standard operating procedures, standard test procedures and other related GMP documentation. Review data for completeness and accuracy
  • Maintain up-to-date scientific knowledge pertaining to the field of analytical chemistry (e.g. theories, practices, equipment and technology), as well as regulatory requirements
  • Work with QA, QC, RA, CMC and MFG to help maintain validation and GMP compliance
  • Schedule use of equipment and coordination of instruments with other QC groups

Work with QA to help maintain GMP and ICH compliance

Your Profile:

  • Ph.D. in Chemistry, Biochemistry or related field with a minimum of 5 years’ experience in peptide/small molecule analytical chemistry or
  • Master’s Degree in Chemistry, Biochemistry or related field with a minimum of 7 years’ experience in peptide/small molecule analytical chemistry or
  • Bachelor’s Degree in Chemistry, Biochemistry or related field with a minimum of 9 years’ experience in peptide/small molecule analytical chemistry
  • Broad knowledge of modern analytical chemistry
  • Hands-on experience with HPLC/UHPLC, IC, GC, LC-MS
  • Experience with Method Development
  • Experience writing standard operating procedures (SOPs) and technical reports
  • Prior supervisory and project management experience
  • Creativity to solve technical and compliance problems
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint. Experience with Microsoft Project is a plus
  • Ability to effectively organize, prioritize, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment
  • Experience with Microbial and Endotoxin Validation will be a plus.