Manager, Reagent Manufacturing Lab - United States
Responsibility for the Reagent Prep and PMP coating areas including scheduling, housekeeping, equipment, equipment maintenance, and training. Responsibility for timely administration of calibration/preventative maintenance activities for all equipment assets. Responsibility for bioburden microbial testing and environmental microbial monitoring in manufacturing and production areas.
- Lead and manage the Reagent Manufacturing Lab
- Manage and harmonize Reagent Preparation Training Program
- Manage the testing and personnel responsible for the environmental and bioburden microbiological testing
- Manage the personnel and processes associated with equipment calibration and traceability
- Manage the personnel and processes associated with Labware Washing
- Manage Reagent Manufacturing build out projects in conjunction with Facilities
- Manage and administer Operations Housekeeping Program
- Develop leadership competencies and foster an environment that results in a risk-taking, energetic, accountable work force that works together to fulfill corporate objectives.
- Recommend, develop and implement plans that support the achievement of the strategic business operations of the company.
- Understand and utilize documentation protocols and complete all documentation necessary for regulatory compliance.
- Develop leadership competencies and foster an environment resulting in a motivated, positive, knowledgeable and accountable support group.
Qualifications Experience Personal Strengths Mobility
- 15+ years industry experience in manufacturing/quality/product development environment with a minimum of 6 years of supervisory responsibility
- 8+ years of industry experience in manufacturing/quality/product development environment with a minimum of 3 years of supervisory responsibility
- Knowledge of safety regulations appropriate to working in a laboratory environment.
- Knowledge of budgeting process and elements of a budget.
- Problem solving ability to allow diagnosis of problems, resolve key issues and implement resolution.
- Interpersonal skills such as the ability to put others at ease and elicit ideas and information.
- Skill at developing and maintaining relationships with internal and external customers.
- Knowledge of regulatory environment pertaining to department functions which affect operations, processes and control processes.
- Knowledge of good laboratory and good manufacturing practices (GMP)
- Decision-making ability and leadership skills
- Functional knowledge of manufacturing equipment and processes
- Project Management experience
- Lean Fundamentals course work/experience or Lean Agent Certification
- Understanding of basic industrial microbiology
- Experience with Equipment Qualification and Process Validation
- Ability to identify potential resources and implement their skills to group needs.
- Ability to utilize financial reports to develop budgets, analyze expenditures versus budgets and to implement cost control measures.
- Skilled at facilitating and directing communications, interactions and decision making within the group and company.
- Ability to initiate and implement policy, systems, and practices in managing people which enhance retention, motivation, reward, coaching, direction, development and separation.
- Ability to give authority and/or autonomy of decision making and action taking to others to better distribute work activities or to develop staff.
- Understanding of employment law.
- Skill at preparing and presenting written materials such as reports, presentations and proposals.
- Advanced MS Office skills
As per local and Company requirements for DiaSorin Molecular LLC.
A competitive compensation package including Medical, Dental, Life, STD, LTD, Company
match of Retirement plan with vesting schedule
Others Information as per Local Legal Requirements
JOB POSTING REQUIREMENT for USA VACANCIES for DiaSorin Molecular LLC
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship
for employment visa status (e.g, TN, H1B status) now or in the near future.
It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons
regardless of age, color, national origin, citizenship status, physical or mental disability, race,
religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic
information, marital status, status with regard to public assistance, veteran status, or any
other characteristic protected by federal, state or local law. In addition, DiaSorin will provide
reasonable accommodations for qualified individuals with disabilities. Our company uses
E-verify to confirm the employment eligibility of all newly hired employees. To learn more
about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
DiaSorin is an EEO/AA employer.
EEO is the Law | http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf