Drug Product Manufacturing Associate II - Formulations

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The Drug Product Manufacturing Associate II – Formulations is responsible for the implementation and execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements.
The Associate II will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate II will optimize and achieve a solid understanding of both the technical aspects as well as the quality systems which govern cGMP manufacturing.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• Performs various routine manufacturing tasks under the guidelines of established Standard Operating Procedures (SOP’s) and cGMP regulations.

• Coordinates the implementation of production and manufacturing procedures and schedules. 

• Performs visual inspection of tanks and bulk drug substances.

• Prepares components, media, buffers, and other solutions as needed.

• Accurately documents, completes, and reviews batch records.

• Expected to focus in various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components.

• Perform manufacturing operations in a sterile suite.

• Coordinates and leads preparation of material and components for sterilization in autoclave or dehydrogenation oven.

• Reliably executes well defined SOPs.

• Required to revise SOP’s according to investigation or audit findings.

• Collaborates with other technical personnel with troubleshooting and engineering activities.

• Collects and disposes of lab wastes according to established Safety, Health, and Environment (SHE) procedures.

• Responsible for routine maintenance and troubleshooting of production equipment.

• Maintains cGMP environment according to the production needs of the Drug Product group.

• May be required to interact and collaborate with clients and third-party vendors.

• Responsible for supporting the management of group production resources.

• Works closely with Production Planner to manage QAD work orders to ensure production materials are obtained according to the manufacturing schedule.

• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].

• 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.

• Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures

• Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• High School Diploma required. Bachelor’s degree in a Life Sciences discipline or equivalent preferred.

• Two to four (2-4) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.

• 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 in a scientific or manufacturing environment.

• Familiarity with cGMP, manufacturing, machine operations, and data entry is required.

• Must be familiar with Microsoft Office applications.

Physical Demands:
 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly r