Drug Product Manufacturing Associate I - Formulations - 2nd Shift

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.

   

Summary:

The Drug Product Formulations Manufacturing Associate I is responsible for 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.

2nd Shift Hours: 2PM-10:30PM

*eligible for a 10% pay differential

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• 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 [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.

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

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a Life Sciences discipline or equivalent preferred.

• 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.

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

• 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:

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

• occasionally stand for extended periods of time, up to four (4) hours/time

• occasionally required to lift up to 50 pounds

• constantly required to view objects at close and distant ranges

• 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 workday, 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 $21.69-$24.41 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.

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For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair-chance