PURPOSEResponsible management of the Microbiology laboratory and personnel and execution of the site Environmental and Personnel Monitoring program. This individual is expected to have strong, hands-on, and technical experience of microbiological assays (Endotoxin, Bioburden, TOC) and Environmental Monitoring.
The Microbiology Manager ensures strict adherence to all cGMP/GMP policies and standard operating procedures, provides microbiology technical expertise, and communications effectively with other departments.
The Manager will also have a proven track record with Continuous Improvement and be a champion for the change within the Microbiology team and the QC organization as a whole.
ESSENTIAL JOB FUNCTIONS / DUTIES- Maintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOP's, guidelines and regulations.
- Coordinate day-to-day management of QC Microbiology operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication cross-functionally.
- Manage and develop the performance of direct reports by setting clear goals, providing performance feedback, supporting career development and recognizing and rewarding exceptional performance.
- Oversee testing in-process samples, drug substance and drug product release/stability and complaint samples.
- Oversee performance of environmental and utility monitoring according to SOP's, sample test requests, and per approved protocols and investigations.
- Maintain data integrity to the highest industry standards,
- Oversee timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies.
- Manage outsourced testing activities as necessary and ensure results are reported in a timely and compliant fashion.
- Develop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management, data archiving, and validation and calibration of QC equipment.
- Engage with Continuous Improvement projects cross-functionally that support site improvements and cost efficiency.
- Support and participate in internal and external inspections and audits including regulatory inspections.
- Collaborate with QC Tech Services for method validation, specification generation, stability studies and support life cycle management of methods, Ref. Std. & Critical reagents.
- Support new equipment validation and implementation.
- Provide QC data internally and internally and actively support and participate in cross functional teams (CMC, Quality Management, Management Review Meetings, SRB etc.).
- Ensure timely issue escalation to Quality senior management and cross-functional support teams.
SPECIAL JOB REQUIREMENTS- Adaptability required as work schedule may change based on business needs
- Criminal background check and drug screen required
- Other duties as assigned
KNOWLEDGE, SKILLS & EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS in Microbiology/ Biology, or related scientific discipline
Essential
ON-THE-JOB EXPERIENCEAt least 8 years' GMP Quality Control experience with at least 4 years management experience
Essential
Advanced knowledge of global, especially US and EU GMP guidelines
Essential
SKILLS / ABILITIESStrong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence
Essential
Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards
Essential
Strong ability to prioritize and operate with a sense of urgency
Essential
Solid organizational, analytical and problem-solving skills
Essential
Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills
Essential
Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
Essential
Strong operational and business acumen
Essential
Exhibits highest integrity and committed to ethics and compliance standards
Essential
Open and transparent in sharing data and information
Essential
COMPENSATION RANGEThe compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:
Manager- $130,00-$150,000
Sr. Manager- $150,000-$170,000
PHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Occasionally lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S BENEFITS- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS- Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
