Technical Manager - Biopharmaceutical
We are currently looking for a Technical Manager to join a leading Biopharmaceutical company based in the Berkshire area.
As the Technical Manager you will be responsible for the technical supervision of Drug Substance and Drug Product manufacturing and testing activities performed via External Contract Networks.
You will provide support across Technical Management, Technology Transfer, Regulatory CMC and Quality while sharing knowledge and best practice across the group.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Technical Manager will be varied however the key duties and responsibilities are as follows:
To coordinate and supervise the work of technical contributors within the External Manufacturing Organisation where as a member of the Technical Team, you will help to build a competent and agile Technical function in support of our client's varied portfolio of externally manufactured products.
As Technical Manager you will act as the External Manufacturing team's primary point of contact with SMEs at CMOs/CTLs, author and/or review key master documents (plans, protocols, reports) to support Technology Transfer activities involving CMOs.
Provide technical writing support for Regulatory CMC activities, including authoring/reviewing of
Drug Substance & Drug Product Module 3 sections of submissions (licences, variations) / responses to regulatory agencies requests for supplementary information (RSIs) / briefing documents in support of Agency meeting requests.
Provide technical support to External Manufacturing Organisation's Quality Assurance staff for the
assessment of change controls (CCs), unplanned events (UEs), impact assessments (IAs), corrective and preventive actions (CAPAs), and out of specification (OOS) investigations.
To be successful in your application to this exciting opportunity as the Technical Manager we are looking to identify the following on your profile and past history:
Relevant degree in a life sciences discipline (i.e Chemistry / Biochemistry / Biological Sciences) with proven experience in the Pharmaceutical / Biopharmaceutical sector in a technical management position supporting technology transfer activities.
Proven industry experience in the preparation and authoring of technical sections of CMC filings for EU and/or ROW markets in relation to Pharmaceuticals / Biopharmaceuticals.
A working knowledge and practical experience with outsourcing with external partners or being the point of contact for products transfers within a CMO / CDMO would be advantageous to your application.
Key Words: Biopharmaceutical Technical Management / External Manufacturing Network / Technology Transfer / Technical Leadership / Pharmaceutical Compliance / Tech Transfer / Regulatory CMC
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development.
We welcome applications for any applicant who fulfil the role requirements for this position.
HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists.
We look forward to helping you with your next career moves.
- Start: 02/06/2017
- Rate: Experience Dependent
- Location: Berkshire,England
- Type: Permanent
- Industry: Pharmaceutical
- Recruiter: Hyper Recruitment Solutions
- Contact: Ricky Martin
- Tel: 0203 225 5120
- Fax: 0203 225 5120
- Email: to view click here
- Reference: J3988
- Posted: 2017-06-02 17:08:08 -
- View all Jobs from Hyper Recruitment Solutions
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