Our client, a world leading Pharmaceutical Company in Sanford, NC is currently looking for a Manufacturing Manager / Technology Transfer / Pharma Industry (REMOTE WORK) to join their expanding team.
Job Title: Manufacturing Manager / Technology Transfer / Pharma Industry (REMOTE WORK)
Duration: 12 months contract, extendable up to 18 Months
Location: Sanford, NC
Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan
Support the technology transfer process team on activities related to successfully transferring current marketed drug product to a new external supplier manufacturing sites. Transfer invvoles multiple products from multiple sending sites transferring to two external supply providers.
Personnel will serve as technical lead for gathering product knowledge, collating into easily analyzed formats, generating usual outputs of data and working with other project work streams on requested deliverables.
Colleague will assist with generating knowledge transfer documents, technology transfer plans and other transfer related documents between sending / receiving sites
Colleague will provide first level review of technical documents generated by receiving site and coordinate internal technical review of sending site / project SMEs.
Colleague will participate/lead cross-functional team meetings between sending and receiving sites
Colleague will support administrative activities for the Workstream such as action/issue item tracking, generation of meeting minutes, coordination of focused working sessions between sending and receiving sites and follow up on actions.
Colleague will be responsible for providing monthly schedule updates to master scheduler
Colleague will interact with engineering, regulatory and laboratory work streams
Technical process understanding of Pharmaceutical Drug Products
10+ years' experience working in a manufacturing environment for small or large volume parenteral
Knowledge of terminally sterilized and / or aseptically processed drug product
Basic understanding of laboratory testing for API and drug product: chemical and microbial
Experience working remotely in a matrixed environment
Proficiency in MSOffice applications
Ability to support teleconference meetings outside normal business hours (ie. 8:00am – 5:00pm EST)
Experience working on technology transfer projects
Experience with risk assessments, FMEAs
Experience working with flexible intravenous infusion bags
Comfortable working with international colleagues, operating in global time zones
Experience using and understanding data output from MS Project or other scheduling platform
Will be supporting technology transfer from one site to another.
Need strong experience with Pharma, drug products, aseptic/sterile process.
Must have 10+ years of experience in a pharma or biologics manufacturing environment.
Prefer BS degree, but will accept Associates with 10-12 years of experience.
Candidate must be comfortable working with colleagues in Europe and be able to work flexible hours for European support.
This is NOT a computer based role candidates should have science based experience with drug product manufacturing!
Role will include leading documentation review/support, process reviews, technical gap assessments, etc.
10+ years Pharma or Biologics Manufacturing experience required
**Mandatory: Pharma + Drug Product + Aseptic/Sterile Process experience! **
Location: remote work but highly prefer candidate to be located in Southeast