Job description
Almac Group is currently seeking a Manufacturing Process Team Leader for our Durham, North Carolina location. The Manufacturing Process Team Leader will be responsible for the day-to-day management of Investigational Use Only (IUO) Clinical Trial Assay (CTA) manufacturing process development, manufacture and release of process controls and assay reagents for CTA delivery and Companion Diagnostic (CDx) development studies.
Responsibilities include but are not limited to:
- Responsible for the manufacture and release of IUO In Vitro Diagnostic (IVD) devices such as process controls and assay reagent batches.
- Act as manufacturing subject matter expert/work package lead for CTA development projects, and provide manufacturing process support for CDx development projects
- Manage the US manufacturing schedule, ensuring that work is completed in a timely and efficient manner, while keeping senior management informed of capacity constraints and resource requirements
- Responsible for maintenance of Manufacturing storage locations and monitoring of storage capacity and regulatory compliance
- Develop and execute manufacturing process development in collaboration with relevant teams to ensure alignment between product specifications and manufacturing capability
- Liaise with Procurement and Quality Assurance to ensure the appropriate supplier agreements and supplier qualifications are in place
Qualifications:
Required Education:
- B.S. in chemical, biological science, or medical laboratory technology from an accredited institution
Preferred Education:
- M.S. in chemical, biological science, or medical laboratory technology from an accredited institution
Required Work Experience:
- Minimum of 4 years of experience with high complexity of molecular testing
Preferred experience:
- Support of customer and regulatory body audits
- People management
- Risk assessment and risk management
- Design control
Required Knowledge:
- Understanding of histology, molecular biology, and genomic testing techniques including nucleic acid extractions (DNA and RNA), qPCR, nanostring and Next-Generation Sequencing (NGS)
- Knowledge of Good Laboratory Practice and Good Clinical Practice Guidelines
Preferred Knowledge:
- Analysis of gene expression data generated from qPCR and Nanostring platforms as well as PCR-derived genotyping data
- Generation/analysis of NGS data (DNA-Seq and RNA-Seq)
What can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
EEO is the Law
EEO is the Law GINA Supplement
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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