Drug Product Manufacturing Associate I - Formulations - 2nd Shift
About The Position
The Drug Product Formulations Manufacturing Associate I is responsible for the execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Manufacturing Associate I will work with the Drug Product Manufacturing team to ensure the successful completion of various cGMP activities. The Manufacturing Associate I will learn and demonstrate proficiency in both the technical aspects as well as the quality systems which govern cGMP manufacturing. This role operates on the 2nd shift, from 2 PM to 10:30 PM, and is eligible for a 10% pay differential.
Requirements
- Zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Demonstrated ability to follow detailed directions, preferably in a scientific or manufacturing environment.
- Must be familiar with Microsoft Office applications.
Nice To Haves
- Bachelor’s degree in a Life Sciences discipline or equivalent preferred.
- Familiarity with cGMP, manufacturing, machine operations, and data entry is preferred.
Responsibilities
- Under the guidance of senior manufacturing operators, performs various routine manufacturing tasks while adhering to the guidelines of established Standard Operating Procedures (SOP’s) and cGMP regulations.
- Supports the implementation of production and manufacturing procedures.
- Performs visual inspection of tanks and bulk drug substances.
- Prepares components, media, buffers, and other solutions as needed.
- Accurately documents data and completes batch records as needed.
- May cross train and/or focus in various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components.
- Expected to perform manufacturing operations in a sterile suite.
- Preparation of material and components for sterilization in autoclave or dehydrogenation oven.
- Reliably executes well-defined SOP’s.
- Assists other technical personnel with troubleshooting and engineering activities.
- Collects and disposes of lab wastes according to established Environmental Health & Safety (EHS) procedures.
- Responsible for routine maintenance of production equipment.
- Maintains cGMP environment according to the production needs of the Drug Product group.
- Regular and reliable attendance on a full time basis.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies PCI's cultural values and aligns daily actions with department goals and company culture.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- a flexible spending account
- a 401(k) plan
- annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
