The Microbiology Manager supervises and coordinates the activities of all Microbiology areas (i.e. Sterility Testing, Microbial Limits, Antibiotic Zone Testing, Antimicrobial effectiveness testing, Mycoplasma, Disinfectant Qualification, Endotoxin, Microbial ID), and provides technical leadership for the department. This role is responsible for coordination of daily laboratory operations to meet established testing requirements and turnaround time commitments to clients. This role will engage in and encourage process improvement initiatives, and will coach those that act as the department lead for these objectives.
- Ensures all Micro activities are in compliance with company SOP and regulatory guidelines. - Oversees the day-to-day operations for the Microbiology department. - Ensures all staff members are fully trained.; expected to coach & develop skills of subordinate staff of non-exempt and front-line supervisors. - Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests. Responsible for successfully meeting client & departmental objectives in a timely manner. - Encourages and coaches those that lead projects for process improvement initiatives. - Maintains and fosters a commitment to the company vision, departmental growth and adherence to quality management systems. - Recruits, trains, develops and retains staff for the effective process of departmental operations. - Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise. - Onboards and validates new laboratory systems and equipment as needed. - Applies statistical analysis for interpretation of project data. - Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements. - Effectively resolves related lab/quality issues and concerns in a timely manner. - Enforces all laboratory safety, security and housekeeping policies and procedures. - Actively contributes to the preparation and coordination of internal audits and regulatory inspections. - Creates strong and effective relationships with clients. - Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses. Remains current with USP/EP/JP/AAMI/ASTM/ISO guidelines. - Other duties as assigned
Education & Experience - Requires a life science degree (preferably in Microbiology or Biology) and at least 4 years of relevant GMP operations experience within the CDMO or Pharmaceutical Industry. And 2+ years in leadership roles. Required Knowledge/ Skills/Abilities Knowledge - Technical skills for wide range of microbial tests - Business acumen - Strong knowledge of laboratory and aseptic techniques - Strong understanding of company SOPs, and regulatory guidance documents. - Strong knowledge of safety procedures and quality compliance for assigned area - Good knowledge of cGMP requirements - Experience with client audits Skills / Abilities: - Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites. - Good analytical and problem-solving skills, with the ability to think strategically. - Strong attention to detail, as well as time and resource management. - Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction. - Promote a safe environment for work. - Comply with the general policy of the company. - Communicate well orally both for - Internal customers and team members - External customers - Ability to write reports and business correspondences. - Ability to listen and respond well to external customers, partners and colleagues at all levels. - Good team and interpersonal skills - Highly goal and result oriented. - Understands how to prioritize tasks according to business objectives and can pursue several objectives simultaneously. - Tackles problems with enthusiasm and curiosity. - Treats colleagues at all levels with respect. - Ability to listen and respond well to external customers, partners and colleagues at all levels. - Highly effective team and interpersonal skills with the ability to work across numerous management disciplines. - Can work independently with a high degree of self-motivation - Very effective listening skills with the ability to hear attentively and process information correctly. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #cb