QC Chemistry Group Lead

PCI Pharma Services; San Diego (CA); On-site; USD 44,000 - 51,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Dental & vision

401(k) plan

Flexible spending

Job summary

PCI Pharma Services in San Diego, CA seeks a QC Chemistry Group Lead to oversee analytical operations across proteins, peptides, small molecules, large molecules, and ADCs. You will drive method transfers, verify assays, and ensure GMP compliance while guiding a diverse team of scientists.

The role requires a Bachelor's in Life Sciences (preferred) and 4+ years in quality control, including at least 1 year of leadership. Strong communication and data interpretation skills are essential.

Qualifications

• Associate's Degree or equivalent required; Life Sciences preferred.
• 4+ years of relevant quality control experience.
• 1+ year of leadership experience.
• Proficiency with Microsoft Office; familiarity with electronic Quality Systems.
• Strong written and verbal communication; detail oriented.

Responsibilities

• Leads and collaborates on method establishment for compendial assays and other chemistry methods.
• Performs routine analysis for pH, osmolality, HVLD, ELISA, CE-SDS, SDS-PAGE, viscosity, moisture content.
• Provides scientific direction and technical problem solving to team members and internal stakeholders.
• Interacts with clients and follows up on client inquiries.
• Reviews data, deviations, OOS investigations and test results; provides conclusions and proposals for future directions.
• Technical writing of investigations for deviations and out of specification reports.
• Ensures maintenance of laboratory instrumentation.

Skills

QC leadership

GMP knowledge

Data analysis

Education

Associate's Degree or equivalent

Bachelor's in Life Sciences preferred

Tools

Microsoft Office

Electronic Quality Systems

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 QC Chemistry Group Lead ensures the fundamental integrity of the laboratory infrastructure. This position oversees routine and non-routine analysis of proteins, peptides, small molecules, large molecules, and ADCs, and supports the development of procedures & initiatives to reach departmental goals.

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Leads and/or collaborates on method establishment (e.g. method verification, qualification, transfers and validations) for compendial assays and other chemistry methods.
• Performs routine analysis and testing for compendial assays such as pH, osmolality, extractable volume, density, particulate matter, HVLD and appearance, as well as ELISA, CE-SDS, SDS-PAGE, viscosity and moisture content.
• Provides scientific direction and technical problem solving to team members and internal stakeholders.
• Interacts with clients and follows up on client inquiries.
• Reviews data, technical reports, deviations, OOS investigations and test results and provides conclusions and proposals for future directions.
• Technical writing of investigations for deviations and out of specification reports.
• Ensures the maintenance of laboratory instrumentation.
• 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 Pharma Services cultural values and aligns daily actions with department goals and company culture.

EDUCATION AND EXPERIENCE:

• Associate's Degree or equivalent required. Bachelor's degree in a Life Sciences discipline strongly preferred.
• Minimum of 4 years of relevant experience in quality control.
• Minimum of 1 year of functional or day to day leadership experience.
• Working knowledge and experience with GMP regulations, good documentation practices, troubleshooting, and data entry.
• 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 laboratory environment.
• Must be proficient with Microsoft Office applications.
• Experience with electronic Quality Systems preferred.

LEADERSHIP RESPONSIBILITIES:

• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Engages employees by creating a climate in which they want to do their best.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains employee work schedules.
• Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.

The hiring rate for this position is $32.92 -$37.04 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.

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.