PCI Pharma Services
Drug Product Fill Manufacturing Supervisor
PCI Pharma Services, San Diego, California, United States, 92189
Drug Product Fill Manufacturing Supervisor
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. 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. The
Drug Product Manufacturing Supervisor
is responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. Responsibilities Oversee daily operations (formulation, filtration, filling and troubleshooting of any issues). Batch record review and generation. Strategic planning with drug product manufacturing and other internal teams including defining schedule, coordinating preparation, and troubleshooting any issues that may arise. Participate in client calls, interactions and meetings including kick off meeting, tours, and resolving operational or quality issues. Participate in internal investigations including deviations, corrective actions, preventative actions, and product quality reviews. Facility planning for shutdowns, maintenance, HEPA certifications, qualifications and media fill planning. Provide audit responses related to Client, QP, and Regulatory Inspections, SOP and Batch record revisions. Interact with the Quality team regarding EM investigations, OOS investigations, and deviation Investigations Regular and reliable attendance on a full-time basis. 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. Leadership Responsibilities Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing. Identifies, recruits, and retains top-notch talent. Champions PCI’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with PCI’s policies and procedures. Requirements Bachelor’s degree in life sciences discipline or equivalent required Minimum of five (5) years of experience in relevant technical experience Minimum of 1 year leadership experience. Understanding of cGMP's. Understanding of regulatory requirements. Solid command of chemistry. Understanding of fillers and processes regarding filling. Understanding of QAD, ACE, LIMS, and RAM. The base salary range for this position is $85,120 - $106,400 plus annual performance bonus eligibility. 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.
#J-18808-Ljbffr
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. 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. The
Drug Product Manufacturing Supervisor
is responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment. Responsibilities Oversee daily operations (formulation, filtration, filling and troubleshooting of any issues). Batch record review and generation. Strategic planning with drug product manufacturing and other internal teams including defining schedule, coordinating preparation, and troubleshooting any issues that may arise. Participate in client calls, interactions and meetings including kick off meeting, tours, and resolving operational or quality issues. Participate in internal investigations including deviations, corrective actions, preventative actions, and product quality reviews. Facility planning for shutdowns, maintenance, HEPA certifications, qualifications and media fill planning. Provide audit responses related to Client, QP, and Regulatory Inspections, SOP and Batch record revisions. Interact with the Quality team regarding EM investigations, OOS investigations, and deviation Investigations Regular and reliable attendance on a full-time basis. 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. Leadership Responsibilities Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing. Identifies, recruits, and retains top-notch talent. Champions PCI’s culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication. Provides oversight and direction to the employees in accordance with PCI’s policies and procedures. Requirements Bachelor’s degree in life sciences discipline or equivalent required Minimum of five (5) years of experience in relevant technical experience Minimum of 1 year leadership experience. Understanding of cGMP's. Understanding of regulatory requirements. Solid command of chemistry. Understanding of fillers and processes regarding filling. Understanding of QAD, ACE, LIMS, and RAM. The base salary range for this position is $85,120 - $106,400 plus annual performance bonus eligibility. 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.
#J-18808-Ljbffr