Newsletter:

Manager in Analytical Development-Quality Control

HELP

CK Group

Beschreibung:	Manager in Analytical Development-Quality Control
Stadt:	Schweiz, Schweiz
Firma:	CK Group - Firma bewerten
Datum:	2024-12-22
Beschäftigung:	bis 100%
Salär:	zu verhandeln CHF - 40 Std/Woche
Arbeitsort:	Schweiz

BEWERBEN

Tasks: Manager in Analytical Development-Quality Control

Manager in Analytical Development-Quality Control

Duration: TBD

RESPONSIBILITIES AND TASKS:
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.

Manages a team of up to 3 direct reports.
Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial).
Organization of laboratory activities. Follow the processes defined in Guidelines and SOP s.
Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, 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
Conduct of release, retest, stability studies, transfer and validation analyses.
Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
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.
Assurance of adequate maintenance and operation of analytical equipment according to GMP.
Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
Organization of GMP-(re)qualification and validation of analytical equipment with external companies.
Elaboration of qualification plans and review of qualification documents.
Ensuring initial and continuing training of the personnel of AD/QC and adaptation according to business needs.
Ensuring of cleanliness of laboratory and workspace.
Independently designs and executes projects or experiments with hands on involvement.
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
Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.

REQUIRED QUALIFICATIONS AND EXPERIENCE:

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, with demonstrated previous success in a managerial function.
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.
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.