Manager of Operations at BioGX in Birmingham, AL
Purpose of the Position:
Responsible for planning, implementation and compliance of Research Use Only and IVD manufacturing systems using good manufacturing practices (GMP) and adherence to quality management system (QMS) requirements. Develop plans, in partnership with key collaborating functional areas within and outside of department, to provide appropriate manufacturing facility and controls to achieve the company’s milestone objectives. The plans include materials acquisition, workflow monitoring, supplier contracts, validation, goal setting, production scheduling, warehousing, shipping and staff development to meet requirements of existing and new products. This person is directly responsible for leadership of the Manufacturing packaging and QC units to develop project plans, projecting and recommending staffing requirements to achieve timelines and maintaining expense controls.
Essential Duties and Responsibilities (other duties may be assigned):
- Accomplishes manufacturing packaging and QC staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Manages, coordinates and executes reagent manufacturing packaging and Quality Control procedures.
- Assist with the compiling and submittal of manufacturing QC data and batch records for QA review and approval.
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures.
- Manage manufacturing packaging and QC personnel and testing schedule.
- Manage development of reagent manufacturing QC processes and documentation.
- Manage, plan and coordinate resources for product stability testing.
- Complies with ISO 13485 and cGMP standards.
- Support continuous quality improvement.
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Completes timely product QC and packaging by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; resolving QC testing issues promptly.
- Maintains high quality by establishing and enforcing organization standards.
- Ensures operation of equipment by identifying problems, calling for repairs; evaluating new equipment and techniques.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
- Contributes to team effort by accomplishing related results as needed.
- Understand, train personnel, and enforce strict adherence to the applicable SOPs of the Quality System, as well as the Manufacturing Guidelines.
- Assist in attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Lead or support Lean Manufacturing initiatives that involve across-functional team (outside of Operations).
- Uses chemistry, biochemistry, and molecular biology knowledge to assist in solving the range of problems associated with molecular tests on diverse platforms.
- Responsible for carrying out work to company standards, including documentation, accurate record keeping, and maintaining related work schedules in order to support product development timelines.
- Performs data analysis.
- Present results at meetings as required and proposes new strategies and methods to address immediate and upcoming technical issues.
- Compiles and submits manufacturing batch records for manufacturing’s review and QC testing.
- Assists in process scale-up to transition from pilot lots to full production-scale manufacturing.
- Assists in forecasting enzyme, oligo primer and probes.
- Performs job functions in compliance with QMS standards.
- Performs additional tasks as assigned.
- Responsible for the coordination and supervision of Manufacturing QC staff.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and coordinate training of employees; planning, assigning, and supervising work; rewarding and disciplining employees; addressing complaints and resolving personnel conflicts and issues.
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience translating development product designs into manufactured products
- Project planning
- Supervisory experience
- Budgetary planning and management experience.
- Specialized knowledge and experience in molecular diagnostics and real-time PCR is required.
- Performance management experience.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
- Working knowledge of cGMP and Quality Assurance systems used in IVD products.
- Practical experience with clinical investigations during research, development, and validation stages, the latter in support of impending regulatory submissions (510k, PMA, etc.).
- Demonstrated familiarity with relevant publications, patents and processes leading to such.
- Understanding of bioinformatics, including nucleic sequence alignments, GenBank searches, oligo primer and probe design for use with Taqman, Scorpions, and other chemistries.
- Firsthand experience with medical devices manufacture (and/or biotechnology pharmaceuticals with knowledge of IVD requirements).
- Possess the skills necessary to create and lead a culture of commitment to the values vital to organizational development and growth.
- Proven ability to deliver productivity to plan.
- Willing to resolve problems.
- Ability to collaborate and work effectively with diverse groups, incorporate the input of others to improve our processes, and align with internal customers.
- Committed to developing and empowering others; to accomplish goals through the skills of persuasion, influence and negotiation.
- Must have excellent communication skills (listening, written, verbal, presentation).
- Ability to interface and exchange information with all levels within the company’s workforce.
- A team player that works with management and technicians to strive for continuous improvement.
- Knowledge of bills of materials and other planning activities.
Education and Experience: B.S. science or engineering or related discipline with at least 2 years leadership experience in an FDA/ISO regulated manufacturing environment.
Language Skills: Must be proficient in writing and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision-making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off