Drug Product Manufacturing Associate II - Formulations

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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 required to sit, and to reach to use computers and other office equipment

• constantly stand for extended periods of time, up to four (4) hours/time and reach to use various lab equipment throughout a process.

• frequently required to lift up to 50 pounds

• constantly required to view objects at close and distant ranges with hand and eye coordination

• frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

*The hiring rate for this position is $26.73 -$30.07 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.