Callum Collier on LinkedIn: #externalmanufacturing #techtransfer #fda #gmp (2024)

Callum Collier

SVP - Quality & Technical Operations

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Any leaders in External Manufacturing having concerns about their ongoing or upcoming tech transfer to a CDMO? Unexpectedly, as of the 1st of July, we’re able to introduce you to a consultant who’s recently helped our client’s CDMO pass a tricky FDA PAI and keep their product on track for launch in 2025. Described as a “10/10” by their previous director @ J&J, get in touch to discuss if you or a colleague are having problems with process scale-up/out, PPQ, or complete TT/AM transfer oversight. Product knowledge: Large (mRNA, vaccines, sterile injectables, biologics) & Small molecules (solids / freeze-dried drug products). #externalmanufacturing #techtransfer #fda #gmp

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Looking for an interim QC Manager for a biopharma client near Amsterdam. Also interested in speaking to consultants with expertise in one of; Deviation Management, Complaints, Cleaning Validation. 6-12 month projects, on-site/hybrid possible. You don't have to speak Dutch, but need to be EU-based and speak English.If you're already in my NL network I'll be in touch this week (if not by Friday, please drop me a reminder). New connections reach out via LinkedIn/email.#qc #qa #gmp #freelance

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Back to work after a couple of weeks off, here’s a list of my active projects heading into the weekend. If interested, reach out via LinkedIn or email (callum.collier@epmscientific.com):CQV Project Lead – South of France, Immediate start.QP (IMP & Commercial) – NL, Q3 start.TT – US to Europe (Radiopharma) – Remote, Q3 start.QC SME – NL, Immediate start.QA SME (Inspection readiness) – NL, Q3 start. QA Validation – NL, Immediate start (short-term).

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Running a couple of searches for engineering teams across Europe in addition to several projects in Quality. Drop me a note if either of the below are of interest and you can start in May/June.Process engineer - Copenhagen, 12-month contract, on-site. Ideal candidate would have experience with single-use bioreactors and co-ordinating CQV activities for downstream equipment (biologics).Automation Engineers – North Brabant (NL), 2 year project, on-site. Key systems; PCS7, PLC-SCADA, BMS. 1st role Process Automation oriented 2nd role focused more on Utilities/Facilities. Biopharma facility.#engineering #freelance #cqv #automation

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  • Callum Collier

    SVP - Quality & Technical Operations

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    I'll be attending BIO-Europe Spring on March 18–20, 2024, in Barcelona. We're looking forward to connecting with our partners, drop me a message if you'll be there! #BioEuropeSpring https://lnkd.in/evwajK_2 . Informa Connect

    BIO-Europe Spring 2024 app.ingo.me

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  • Callum Collier

    SVP - Quality & Technical Operations

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    For Quality Heads/Directors looking for urgent quality support for Audit/Warning Letter remediation please take a look at the below:- This project was complete with 8 hires across 3 work-streams (QA, Microbiology, Analytical).- Time taken from initial request to final on-boarding - 21 days. - All consultants have been vetted/referenced.- 1-stage interview process.- Avg. time from CV represented to first day on-site was 10 days. Due to this great work from; Annabelle Wallace, Daniel Moruzzi, Henry Pegley, Ryan O’Reilly, Habiba Hire, we were asked to take on an additional project (7+ hires) which is also close to being finalised. Please connect to discuss your project demands, most are surprised to learn we're often more cost-effective than the equivalent consultancy partner's quote. #audit #remediation #fda

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  • Callum Collier

    SVP - Quality & Technical Operations

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    2x Process Engineers (Aseptic experience a must) required for a facility expansion project in Southern Europe. ~2 year project starting with hybrid/remote working, scaling up on-site work throughout. #processengineering #freelancejobs

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Looking for 10+ Analytical/Batch record reviewers for an accelerated q-system audit project, start date ASAP. Open to varying experience levels however all applicants should ideally have 3+ years in a GMP facility (lab or mfg). Project will be for ~2 months on-site in Northern Europe. If you're between projects, due to finish, or are currently out of work, drop me a note on this. We can offer engagement as a freelancer or on payroll. #audit #analyticaldevelopment #microbiology #qa #qc

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Updated project list before the long King's Day weekend. If interested in any of the below, drop me a note.Netherlands:- Project Engineer (C&Q, project scheduling): Nth Holland- Process Engineer (C&Q, process equipment): Limburg- Quality consultant (RP, GDP, Q-system set-up): Nth Holland- Quality specialist (QA oversight to TT, Process Validation), Sth HollandRemote:- Technical Writer (DS, DP filings for BLA) - June/July start- Quality Engineer (Combi product, DHF creation, system set-up) - June#freelance #netherlandsjobs #cqv #gmp #gdp #qajobs #engineeringjobs

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  • Callum Collier

    SVP - Quality & Technical Operations

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    Remote project - Quality Engineer, Combination ProductLooking for a consultant who's been directly involved in the preparation of a Combination Product for clinical use through to market authorisation. This is for a key biotech partner of ours in Europe. Experience required in: Q-systems, CMO Management (fully virtual company), Design control (21 CFR 820.30), Design process development, Risk assessments, Regulatory filings for combination products. On offer - 12 month contract, open to offers on FTE (20hrs p/wk+), occasional travel to site. #medicaldevice #qualityengineer #combinationproducts #remote

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Callum Collier on LinkedIn: #externalmanufacturing #techtransfer #fda #gmp (26)

Callum Collier on LinkedIn: #externalmanufacturing #techtransfer #fda #gmp (27)

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Callum Collier on LinkedIn: #externalmanufacturing #techtransfer #fda #gmp (2024)

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