Project Lead, Production

ALMAC Group; Souderton (Montgomery County); Hybrid; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical, Vision & Dental

20 days PTO per year

12 holidays per year

Disability & Life Insurance

401k company contribution

Hybrid work

Professional development

Job summary

Almac Group is seeking a Project Production Lead in Souderton, PA to drive and execute manufacturing requirements for clinical materials per customer protocol. The role focuses on delivering production and customer service deliverables for manufacturing activities within a high-compliance environment.

Qualifications include a HS diploma with 4+ years experience or an Associate's, with preference for a Bachelor’s in Science or related field.

Qualifications

• HS diploma with 4+ years relevant work experience or Associates Degree.
• 1+ years Project Management and/or Operational experience.
• Bachelor's Degree in Science or business-related field preferred; GMP/GCP knowledge advantageous.

Responsibilities

• Drive completion of production activities to ensure timely packaging and release of finished goods in compliance with GMP.
• Serve as primary contact for customer and Clinical Supply Manager on Production activities.
• Review and approve materials management information and ensure COSMOS protocols are correctly set up.

Skills

Project management

Client-facing

GMP knowledge

GCP knowledge

Operational excellence

Education

HS diploma with 4+ years experience

Associates Degree

Bachelor's Degree preferred

Tools

COSMOS

Job description

Almac Group is currently seeking a Project Production Lead for our Souderton, PA location. The Project production lead's main objective is to successfully drive and execute the manufacturing requirements of clinical materials for a protocol per customer requirements at any Almac Clinical Services Site

Responsibilities include but are not limited to:

• Drive the completion of all production related activities necessary to ensure timely and efficient packaging and release of finished goods, ancillaries, and samples, ensuring full compliance with current Good Manufacturing Practice. Assume ownership for the delivery of production and customer service deliverables related to manufacturing activities
• Serve as the primary contact and subject matter expert to the customer and Clinical Supply Manager for Production activities, communicating status, issues, questions, and outstanding information to the internal and external team. Advise the customer and Clinical Supply Manager of any issues or delays arising throughout the course of the project, suggesting mitigations, as appropriate, ensuring internal issues have been resolved effectively.
• Review and approve information/documentation required for the management of the materials required for production. Verify protocols in COSMOS are set up accurately for production.

Qualifications:

Required Experience / Education:

• HS diploma with 4+ years relevant work experience or Associates Degree
• 1+ years Project Management and/or Operational experience

Preferred Experience / Education:

• Bachelor's Degree in Science or business-related field highly preferred
• Pharmaceutical industry, clinical supplies, health care, or clinical trial
• Project management experience within a manufacturing environment
• Client-facing position or customer service related
• GMP and/or GCP knowledge

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 as well as one day for Annual Diversity Day
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Hybrid work available for applicable roles
• Professional development programs/ continuous learning opportunities

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 over 7,500 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.

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 [e-mail] to request assistance.