analytical development scientist

Job Title: Analytical Development - Quality Control Manager

Work Location: Allschwil

Country: Switzerland

Schedule: Fulltime (100%)

Desired start date: ASAP

Duration: 12 MONTHS

Job Responsibilities

Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

The Manager working in AD/QC will have the following responsibilities and tasks which are related to Viatris Innovation, Allschwil, Switzerland.

•Responsible for Analytical Development and Quality control for assigned CMC program in late stage development (typically phase 3 and commercial).

•Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .

•Point of contact and supervision for analytical 3rd parties' labs, e.g., CMOs and CROs, for defined analytical tasks.

•Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.

•Representation of AD/QC in technical project team and CMC team meetings.

•Oversight for release, retest, stability studies, transfer and validation analyses conducted by analytical service providers.

•Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records.

•Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.

•Write-up and review of analytical protocols and reports and establish specifications.

•Drafting and review of applicable CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.

•Independently reviews scientific work in project related activities.

•Independent evaluation and development of novel analytical techniques and instrumentation as applicable at 3rd parties.

•Experience interacting with regulatory agencies and responding to analytical queries is a plus.

•Strong understanding of analytical CMC requirements, including generation and review of data packages to support quality section of regulatory submission.

•Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management.

•Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues

interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings.

•Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.

•For the assigned analytical function, set and accomplish product development timelines working closely with the relevant Technical Project Leads (DS/DP/IDD).

•Responsible for the analytical expertise for assigned program drug substances, drug products and/or Integrated Drug Device.

•Summarizing, defending and communicating results and product quality issues to management.

•Manage the applicable outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.

•Participate in technology transfer between laboratories, both internal and external to the company.

Candidate Requirements

•College-, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry.

•In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.

•Personality and disposition to manage professionals effectively in a matrix system. Diligent attention to details.

•Willingness to limited travel.

•Mature stable person with a positive and dynamic demeanor.

•High flexibility, superior communication, time-management and team-working skills. Ability to work independently and to take initiative.

•Proficient in English.

•Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.

•Ability to complete assignments, meeting quality- and time-oriented objectives.

•Strong skills in timeline development and management.

•Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams of people with multiple perspectives, culture and talents, capable of functioning as individual contributor or team leader.

•Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development. Experience in the development and performance of analytical tests for a variety of drug substances and product