Drug Product Manufacturing Associate I - Formulations - 2nd Shift
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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy…
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$20/hr–$25/hr
Entry level
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$21/hr–$24/hr
Full-time
bachelor degree
Paid Time Off, Health Insurance, Dental Insurance, Vision Insurance, Flexible Spending Account, 401(k) Plan
Posted 14d ago
~40 hrs/week
Responsibilities
The associate is responsible for executing routine production and manufacturing procedures to support drug product formulations while ensuring regulatory compliance. Key tasks include preparing buffers and media, performing visual inspections, and maintaining a sterile cGMP environment.
Requirements
A bachelor's degree in a Life Sciences discipline is preferred, along with zero to two years of relevant experience in manufacturing or laboratory settings. Candidates must be detail-oriented with the ability to follow strict SOPs and communicate effectively.
Full job description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
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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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: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
Related keywords
Drug ProductFormulationscGMPSOPSterile SuiteLife SciencesBatch RecordsEnvironmental Health & SafetyEHSBiopharmaManufacturingSterile FiltrationAutoclaveDehydrogenation OvenIn-process Testing
We are PCI Pharma Services. CDMO.
Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow.
We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
Clinical Trial ManufacturingPackagingStorageand Global DistributionAnalytical Development and TestingCommercial PackagingQP ServicesFormulation Development and Drug ManufacturingSterile Fill-FinishLyophilization Manufacturing Services
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