ADQC Manager Biologics
Publication date:24 November 2022
Place of work:Hegenheimermattweg 91, 4123 Allschwil
ADQC Manager Biologics
ADQC Manager Biologics
Basel, BS, CH
About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for an enthusiastic and motivated ADQC Manager in Biologics to join our dynamic team !
Job Responsibilites :
- Manages a team of up 3 direct reports
- Responsible for large molecules projects from early phase to late stage projects (phase 3 and commercial).
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOP's.
- Development, optimization and implementation of analytical methods for large molecule in vaccines 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
- 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.
- Independently reviews scientific work in project related activities.
- Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Independent evaluation and development of novel analytical techniques and instrumentation.
- Leverages workload of respective project members to assure timelines and budget are met.
- 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.
- Set and accomplish product development timelines working closely with formulation scientist.
- Responsible for the management of the GMP laboratory and employees
- Responsible for the analytical expertise for defined Idorsia drug substances and/or drug products
- Summarizing, defending and communicating results and product quality issues to management
- Manage the 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.
- Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures
Candidate's 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 with demonstrated previous success in a managerial function
- Strong background in analytical chemistry of large molecule
- Knowledge of the GMP/regultory requirements
- 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
- Broad knowledge in analytical chemistry of large molecule
- Background in Elisa, Western blot, lowry methods....
- 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 products
What Idorsia offers :
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous benefits
Work Location: Basel Area - Allschwil
Business Area: Pharmaceutical Development - Analytical Development and Quality Control - Drug Product
Job Type: Permanent
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.