Manager, Product Delivery at BioGX – Birmingham, AL
Purpose of the Position: Management of Product Delivery staff by organizing and monitoring the areas of Design Transfer, Production, and Quality Control (QC). This involves coordinating with R&D scientists for all steps requiring the testing and transfer of new products to Manufacturing, overseeing production and test/validation builds and QC work-flow, maintaining quality systems compliance, planning, schedules, resources, and product QC testing for release and shipping. Assist Research and Development (R&D) scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage production build, product transfer and QC staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, training, counseling, motivating, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- 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.
- Work with the R&D staff to transfer developed products, managing the scale-up to transition from pilot lots to full production-scale manufacturing.
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development and product transfer problems associated with genetic tests for the presence of specific DNA and RNA sequences as required.
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product transfer for timely completion of project(s).
- Maintain current knowledge of competitive technologies, new principles and theories relevant to product R&D, product transfer, and commercialization in an ISO 13485 mfg. environment.
- Designs, prepares, dilutes, aliquots, and maintains DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
- Document product transfer protocols, results of studies and process design/development history to meet QMS requirements.
- Works with BioGX Marketing dept. to prioritize product releases.
- Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
- Assist in attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Manages, coordinates and executes reagent manufacturing build, product transfer and Quality Control procedures and schedules.
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures.
- Manage, plan and conduct 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 delivery by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; resolving Product Delivery 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.
- Serves as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
Supervisory Responsibilities: May supervise one or more depending upon project scope.
- Responsible for the coordination and supervision of Product Delivery 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 problems.
- Assist in attaining quarterly and annual production goals
- Learn and enforce company safety policies and practices.
- Lead and/or support Lean Manufacturing initiatives.
Qualifications: To perform this job successfully, an 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 of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Familiar with the use of Arrhenius and stability relationships to establish product stability claims.
- Direct experience with ISO design control procedures and participation in development, verification, validation stages of technology transfer into a GMP manufacturing unit.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience.
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions.
- First hand 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: The ideal candidate will have a Ph.D. or equivalent degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to succeed in the job function.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
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. Assist Research and Development scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Job Type: Full-time
Salary: $60,000.00 – $70,000.00 per year
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off