The Chromatography Forum

of Delaware Valley

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role: Responsible for managing QC projects for clinical and commercial drug products (early phase development and later phase development included) and providing technical communication to clients regarding these drug products on behalf of the QC Laboratories. Responsible for QC Systems which includes data integrity for QC labs, electronic data capture systems, stability, data review and associated teams.

Major Position Activities & Responsibilities:

Responsible for the supervision and career development of the QC data reviewers (Qualified Scientists), Stability Coordinator, and QC Systems team

Responsible for the supervision and career development of the QC Validation team that is responsible for method validations, transfers, and client support

Responsible for QC data integrity and the oversight of QC electronic data capture systems (Empower, Nugenesis, etc)

Represent QC laboratory in a technical expert capacity on analytical and microbiological methods and laboratory investigations in communications with clients and internal Operations, QC Validation group Support, Quality Assurance and Technical Support departments

Lead and manage data integrity related deviations and OOS investigations within the laboratory for new development or later phase clinical drug products.

Communicate with clients the status of these investigations.

Develop, write and revise GMP documentation for method qualification protocols, raw material, in-process and finished drug product test specifications, analytical and microbiological methods, validation master plans etc. This may also include management of change controls for QC projects

As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. And the employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training Performs special projects and other duties as assigned Responsible for Environmental, Health, and Safety compliance Participate in regulatory inspections of the facility (e.g. FDA, MHRA, ANVISA) and customer inspections of the facility Required to be qualified for Good Documentation Practices or GDP prior to execution of GMP tasks

Scope: This position will have responsibility for up to nine personnel as direct reports. The position will be responsible for the Quality Control technical oversight for data integrity, projects and systems and accurate communication to clients and site project management of new drug products that have been introduced to the facility.

Minimum Qualifications: B.S. degree with a major in Chemistry or related science Ten years or more of experience in a pharmaceutical manufacturing Chemistry and/or Microbiology Lab (includes five or more years supervisory experience). Commensurate experience with advanced degree will be considered

Preferred Qualifications:

Technical expertise with analytical methods for a wide range of sample types (chromatographic including the various detector types, spectroscopic, physical etc.)

Technical expertise with microbiological methods for a wide range of sample types (sterility, endotoxin, particulate matter, bioburden)

Knowledge of QC electronic systems operations, data integrity in a QC laboratory, Microbiology and environmental systems operations experience, GMP testing/manufacturing environment expertise, and analytical method transfer, qualification, and validation

Project management skills are essential for successful completion of QC project tasks

Ability to communicate at all levels in a pharmaceutical organization and with external clients

Good interpersonal skills are a must

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team! If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html