Manufacturing Manager I
GENERAL SUMMARY OF POSITION:
The Manufacturing Manager I is responsible to manage and oversee the manufacture, assembly, and labeling of clinical and commercial biologic products. Manages the operation of manual and semi automatic and automated production equipment. Ensures all manufacturing work complies with cGMP guidelines.Responsibilities
- Manages cGMP clinical and commercial manufacturing of biologic products. Ensures that product is released in a timely manner and meets all required specifications.
- Ensures that set-up, sterilization, cleaning and
- maintenance of process equipment and manufacturing runs adhere to schedule.
- Troubleshoots procedures and equipment. Collaborates with Mfg Compliance to conduct root cause investigations of problematic manufacturing runs and makes recommendations to improve runs.
- Assists in validations and performance qualifications of equipment and/or processes. Assembles and analyzes data. Collaborates with Manufacturing Compliance Managers, QC, and QA to ensure that all quality requirements are met.
- Ensures that all necessary materials and equipment are available for manufacturing runs.
- Ensures that all required documentation is complete and accurate, including but not limited to, SOPs batch records and in-process forms
- Makes recommendations for cost effective improvements to MassBiologics’ manufacturing procedures.
- Trains and supervises manufacturing associates and technicians within the department.
- Performs additional job related duties as required.
- Requires a Bachelors degree Biology or Chemistry preferred and a minimum of 2 years of relevant experience including 1 year of supervisory or management experience or equivalent
- Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluations
- Ability to motivate personnel to work effectively and efficiently
- Ability to maintain thorough working knowledge and proficiency in applicable CFR 21 regulations and all current procedures within biologics manufacturing
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems
- Excellent problem solving skills as well as time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
- Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
- Ability to work off shift hours as required; ability to lift up to 50 pounds using proper lifting technique.