Please complete the CAPTCHA to continue
@genzyme.com
✓
2 phones found area 617
✓
LinkedIn matched
A concise factual answer block for searchers comparing this professional profile.
Jenn Lambert is listed as Biopharma/Cell and Gene Therapy Quality Assurance Professional at enGene, based in Watertown, Massachusetts, United States. AeroLeads shows a work email signal at genzyme.com, phone signal with area code 617, and a matched LinkedIn profile for Jenn Lambert.
Jenn Lambert previously worked as Associate Director, QA Operations at Engene and Quality Manager at Azzur Group. Jenn Lambert holds Bachelor Of Science, Bachelor Of Arts, Chemical Engineering, German from University Of Rhode Island.
This section adds company-level context without repeating Jenn Lambert's masked contact details.
AeroLeads found 1 current-domain work email signal for Jenn Lambert. Compare company email patterns before reaching out.
Resourceful and adaptable Biotech Industry Professional with diverse experience in Biopharmaceutical manufacturing for Contract Manufacturing Organizations and Biotech facilities. Strong Quality Assurance background with 15+ years of experience. Knowledgeable in upstream and downstream biotechnology operations with Program Management experience. Demonstrated ability to apply technical knowledge to multiple aspects of the business and provide project support where it is most needed. Accustomed to daily interaction with customer representatives and members of multidisciplinary teams to determine manufacturing priorities and providing necessary support for meeting business and project timelines.Specialties: Experienced with cGMP systems including deviations, change control, CAPA and documentation.Strong knowledge of regulatory guidelines governing the manufacture of Active Pharmaceutical Ingredients (API), including but not limited to ICHQ7, 21CFR Parts 210, 211, and 820, EudraLex Volume 4.
Listed skills include Gmp, Capa, Quality Assurance, Change Control, and 14 others.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
St-Laurent, Quebec, Ca
Provide oversight of GMP partner sites to ensure compliance with manufacturing processes, standard operating procedures, and regulatory guidelines. Manage product disposition activities and ensure proper execution of investigations, CAPA, and change controls.
Paris, France, Fr
Responsible for managing technical, compliance and other business improvement programs for the BulkManufacturing department at Allston Landing. Direct phases of projects from inception throughdelivery to the Bulk Manufacturing department. Coordinate the preparation of proposals, projectplans, change and training strategy and operational readiness factors. Establish milestonesand monitor adherence to master plans and schedules, identify program problems and obtainsolutions, such as allocation of resources or changing course. Direct the work ofemployees assigned to the program from technical, manufacturing and administrative areas.Managed consent decree remediation tasks for the control and evaluation of process contact consumables. Aligned program requirements with company practices and policies. Identified all process contact consumables for the Allston Landing Facility, ensured purchasing controls were in place and evaluated materials for suitability and compatibility with the process. Defined materials requiring further evaluation via leachable and extractable studies and assisted in the design and approval of L&E testing plans. Received verified status for the control of process contact consumables through the third party consent decree verification.
Paris, France, Fr
Responsible for working crossfunctionally to design and implement remediated quality systems which align to corporate standards and address work plan requirements. Provided quality insight to design plans to ensure that holistically systems were compliant and sustainable.
Represented quality assurance through the design, build, qualification and successful licensing of a state of the art manufacturing facility. Provided quality oversight for the development and implementation of all GMP procedures required to perform commercial manufacturing. Designed and implemented a batch lot numbering process which aligned with company procedures and ensured lot traceability for a continuous perfusion cell culture process. Coached and mentored new employees as staffing was increased to support daily GMP operations. Participated on multiple tech transfer projects overseeing the quality assurance aspects to ensure that critical quality aspects, documents and compliance attributes were not overlooked. Monitored the compliance of the facility and supported regulatory inspections to obtain commercial licensing.
Basel, Ch
Support quality operations associated with a licensed drug product. Provide daily suite support including review and approval of event comments, deviations, process change controls and all related GMP documentation. Interact daily with internal and external customers to ensure the continued support and compliance of GMP operations.
Basel, Ch
-Audit vendors and manufacturers of critical raw materials-Conduct internal audits -Support customer and regulatory audits-Conduct cGMP training
Basel, Ch
- Developed and maintained relevant policies and SOPs associated with raw material and vendor qualification-Coordinated the vendor qualification program-Represented supply chain during customer audits and regulatory inspections
Basel, Ch
-Managed site raw material program including 13 individuals responsible for facility wide raw material testing and release.
Temporary validation position supporting facility validation activities
6 month engineering internship in Stuttgart Germany
Temporary position- Summers of 1995 and 1996
Quick answers generated from the profile data available on this page.
Jenn Lambert works for enGene.
Jenn Lambert is listed as Biopharma/Cell and Gene Therapy Quality Assurance Professional at enGene.
AeroLeads has found 1 work email signal at @genzyme.com for Jenn Lambert at enGene.
AeroLeads has found 2 phone signal(s) with area code 617 for Jenn Lambert at enGene.
Jenn Lambert is based in Watertown, Massachusetts, United States while working with enGene.
Jenn Lambert has worked for Engene, Azzur Group, Vor Biopharma, Thermo Fisher Scientific, and Ipsen.
You can use AeroLeads to view verified contact signals for Jenn Lambert at enGene, including work email, phone, and LinkedIn data when available.
Jenn Lambert holds Bachelor Of Science, Bachelor Of Arts, Chemical Engineering, German from University Of Rhode Island.
Jenn Lambert is listed with skills including Gmp, Capa, Quality Assurance, Change Control, Validation, Quality System, Biotechnology, and Fda.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contacts