Boston Analytical is a premier cGMP compliant laboratory, FDA & DEA registered, ISO/IEC-17025:2005 certified for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical Device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction, and to the fast and accurate analysis of our clients' products.
The Associate Director (AD) of Microbiology works closely with the Director of Microbiology to meet the needs of the department. The AD of Microbiology is responsible for the design and implementation of novel testing protocols and instrument validation. The AD is responsible for overseeing the scheduling and prioritizing of work to meet customer expectations, performing all work in compliance with the quality, health and safety objectives of the company. The AD of Microbiology also provides technical support to Microbiologists and Group Leaders to ensure they have the resources they need to meet client deadlines. Works closely with the Director of Microbiology in all aspects related to staff management including training, hiring, conducting feedback sessions, employee development, retention and engagement. The AD has direct responsibility for improving production efficiency while meeting the financial and service goals of the laboratory.
The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
PRIMARY DUTIES AND RESPONISIBITIES
- Champions new technology implementation, including the validation of instruments.
- Leads the development and implementation of process improvement initiatives that promote increased productivity for each product line.
- Works closely with clients to understand custom testing protocol design and implementation.
- Distributes work to Group Leaders to maximize productivity.
- Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
- Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with the Group Leader and Microbiologists.
- Devises and develops processes and methods for the solution of technical problems.
- Trains, mentors and supervises Group Leaders on an as needed basis.
- Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Responsible for overseeing Group leaders in scheduling work in support of maintaining all deadlines.
- Designs and implements processes that ensures that laboratory supplies, consumables, and standards are available to perform the analyses within the required project turnaround time.
- Communicates project delays, quality and or technical issues to the Microbiology Director.
- Reviews lab nonconformance with Group Leaders and Microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.
- Provides regular ongoing performance feedback while serving as a coach and mentor.
- Responsible for developing and communicating goals to Group Leaders and associated microbiologists.
- Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Documents work in a clear and organized manner.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
REQUIREMENTS & QUALIFICATIONS
Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline is required. Must have laboratory experience with a minimum of 5 years of related work experience combined with a Master’s degree or Bachelor’s degree. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS and ELN.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.
MINIMUM SKILLS REQUIREMENT
- Demonstrated skills in laboratory techniques.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
Boston Analytical is a growing pharmaceutical contract lab providing quality Analytical and Microbiological testing services. We are known for our quality and believe our success is driven by our employees. We provide our employees with a state-of-the-art work environment, excellent benefits and opportunities for development.