Manufacturing Site Manager - Tampa, FL | Biospace
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Manufacturing Site Manager

Aimmune Therapeutics

Location:
Tampa, FL
Posted Date:
6/19/2017
Position Type:
Full time
Job Code:
17-52-MG-N
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, Manufacturing,

Job Description


Aimmune is recruiting for a highly motivated individual who will take on the overall responsibility for managing operations at Aimmune’s Contract Manufacturing site in Tampa, Florida.  The Site Manager will have overall responsibility for the planning, direction and control of all operations necessary for the safe, GMP-compliant manufacture and timely delivery of Aimmune’s bulk peanut allergen drug products.  In addition, the individual is responsible for development and implementation of programs to minimize manufacturing costs through effective utilization of personnel, equipment, facilities and materials. Demonstrated experience in managing cGMP manufacturing plant operations and participating in overall production operations efficiency activities are prerequisites for this position. The site manager will be located at our manufacturing plant in the Tampa, FL area.

ESSENTIAL DUTIES:

•   Ensure the timely manufacture, testing, and delivery of drug product according to project timelines and/or product forecasts
•   Ensure the safe operation of the facility in compliance with cGMPs and all applicable regulations
•   Promote a culture of quality and compliance, and create and track metrics demonstrating continuous improvement in site operations
•   Manage a multi-product manufacturing department, and other supporting groups.
•   Work with project management, QA/QC, process development scientists, engineering, and materials management and propose initiatives to gain operations efficiency
•   Work in close coordination with Aimmune’s Brisbane corporate office to plan, lead, and manage the peanut program commercial readiness and other program activities in support of PLI-readiness
•   Identify and implement emerging industry standards and methodologies to prepare the site for regulatory inspections
•   Work with outside vendors and maintenance personnel to implement and manage a robust plant maintenance program with a keen sense toward minimizing costs
•   Proactively manage operations to minimize capacity constraints due to manufacturing and/or test equipment and other resources
•   Manage and partner with Quality group to report, investigate and resolve deviations encountered during GMP production
•   Participate in the design, construction and commissioning of manufacturing facility expansions and other major capital improvements

Requirements


Education and/or experience:

•   BS or MS in sciences or relevant technical discipline, with 15+ years of biopharmaceutical experience in a manufacturing operations environment
•   Excellent working knowledge of cGMP requirements including FDA and EU guidelines as they relate to commercial drug product manufacture
•   Demonstrated experience serving as Plant Manager/Site Head for a pharmaceutical production operations facility
•   Experience with manufacture of solid oral dosage forms (capsules) desirable
•   Ability to travel up to 10% of the time

About Aimmune Therapeutics, Inc.

Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food allergies.  The lead product, for the treatment of peanut allergy, is currently in Phase 3 clinical trials. For more information, please visit www.aimmune.com.

Aimmune Therapeutics offers a competitive compensation and benefits package.

Aimmune Therapeutics is an Equal Opportunity Employer.

Qualified candidates should forward a resume and cover letter, including a statement of interest, availability, and experience, with the job title in the cover letter.

Principals only; no recruiters please.