US ~ Boothwyn, PA
Manager, GMP Manufacturing
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Manages, coordinates and monitors the manufacturing activities of the CTM and commercial operations and interacts with project management in the introduction of new products and processes; maintains the achievement of capacity and production requirements based on the weekly schedule; leads initiatives to improve productivity of operations.
The essential functions of the position include, but are not limited to:
- Interacts with clients and vendors to ensure project timelines are achieved and offering satisfactory alternatives if necessary.
- Ensures the training or re-training of GMP Operators is current in the proper performance of assigned duties in accordance with SOPs, OJTs and cGMPs and all company regulations.
- Directs the workflow of operations for the project teams with daily communication between project leaders, and floor supervision.
- Reviews and updates existing Master Batch Records for critical manufacturing steps, Standard Operating Procedures
- (SOPs) for equipment/room set-up, operation, disassembly and cleaning procedures.
- Assures that assigned operations are conducted in accordance with cGMPs, batch records , or any other company approved documentation that provides direction and instruction in the manufacturing of products.
- Ensures key performance indicators that have been agreed upon by senior management are being achieved on a monthly basis and provides improvement on areas that are falling below the specified targets.
- Interacts with other departments to ensure project activities are performed in a timely manner.
- Participates in assisting QA to establish root cause analysis and providing possible resolutions for process deviations, investigations and CAPAs.
- Assists supervision in the troubleshooting of processing equipment and contacts maintenance for all repairs when necessary.
- Sets individual and departmental objectives, monitors progress and prepares annual performance appraisals for direct reports; reviews in direct staffs appraisals.
- Addresses employee complaints and works with department heads and/or Human Resources, as necessary to resolve employee issues.
- Continues to increase knowledge of latest process technologies within the pharmaceutical industry.
- Reviews product batch records for accuracy of entries, compliance to established limits, specifications and presence of all verification signatures.
- Coordinates personnel activities, ie, vacations, sick time, etc. to ensure there is appropriate coverage in the manufacturing department at all times; addresses personnel issues with the assistance of Human Resources/and or department heads as they arise; assist in training, counsel and disciplining personnel as needed; composing performance improvement plans (PIP) for GMP Operators and reviewing with department heads and Human Resources; and selecting applicants for job openings.
- Conducts department and /or shift meetings with employees as necessary to communicate company information, audit updates, production schedule updates, etc.
- Attend daily production meetings to provide updates on the weekly project schedule.
- Additional functions and responsibilities as needed or assigned.
Essential Specialized Knowledge and/or Skills to Perform Job:
- Ability to read, write and speak English fluently.
- Ability to communicate effectively to team members on a routine basis
- Knowledge of cGMPs, manufacturing procedures of the product line and company policies/regulations; knowledge of manufacturing operations guidelines - SOPs, FDA, OSHA, DEA and MSDS requirements.
- Competency: To perform the job successfully, an individual should demonstrate the following competencies:
- Analytical - Working knowledge of cGMPs and internal SOPs: identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.
- Customer Service - Responds to requests for service and assistance with professionalism, courtesy and confidence.
- Technical Skills - Leadership skills, ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action.
- Interpersonal Skills - Interacts with management and non-management employees across all departments and outside clients.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications.
- Team Work - Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas.
- Diversity - Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings.
- Ethics - Works with integrity and ethically; maintains confidentiality
- Professionalism - Treats others with respect and consideration.
- Attendance/Punctuality - Is consistently at work and on time.
- Dependability - Follows instructions, responds to management direction; takes responsibility for own actions.
- Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
- Safety and Security - Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements.
- Education/Experience: B.S. degree preferred but not required. Minimum of 5 years’ experience in a managerial role within the pharmaceutical industry.
- Language Ability - Ability to read, write and interpret documents such as safety rules, operating and maintenance instructions, and procedures manuals.
- Math Ability - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percentages.
- Reasoning Ability - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Computer Skills - Basic computer skills, i.e., Outlook, Microsoft Word, Excel and Powerpoint
Work Environment and Physical Demands:
- The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job.
- While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell.
- The employee must occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.
- Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing.