This position covers second shift, 3:00 to 11:30 pm. Job Summary:
- Manages compliant, safe, cost-effective, and efficient analytical testing of raw materials, manufactured product intermediates and finished products according to established procedures and specifications, while in full compliance with current Good Manufacturing Practices and Roche's corporate principles, quality policies and standards.
- Strong theoretical and practical knowledge of current PCR and analytical systems, (chemical/radiological/biochemical; e.g. PCR, H/UPLC, AA, LC-MS) processes, test methods and equipment preferred.
- Technical resource that oversees and directs the development, planning, implementation, maintenance and continuous improvement of testing methods, processes and equipment for new or existing products and technologies in collaboration with Operations, DTTS/Process Development and Quality.
- Leads, selects, mentors, develops and evaluates employees to ensure the efficient operation of the function.
- Effectively manages staff which conduct testing and other routine activities. Is responsible for the accuracy, quality and timeliness of testing activities and product supply ensuring market demands are met in adequate time and quantities.
- Ensures that staff are appropriately trained and qualified for the activities they perform.
- Ensures that work group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO).
- Provides developmental plans for direct reports and conducts on-going performance management activities.
- Keeps leaders informed of product and project status, particularly of significant observations and results in critical areas.
- Ensures cGMP compliance and inspection readiness for equipment, premises, and infrastructure all reporting laboratories at all times. Actively supports inspection activities.
- System owner of testing systems/software.
- Ensures the validated state of equipment and testing procedures within the area of responsibility.
- Represents Operations in defining, performing and refining investigations, validation and technical transfers. Analyzes complex data using the required system and various data analysis software. Leads investigations, forms conclusions and makes recommendations.
- Continuously monitors deviations and define and implement sustainable measures to reduce deviations.
- Promotes problem identification and a culture of proactive problem prevention. Provides and implements process and document improvements.
- Prepares documents and reports (e.g., SOPs, Variances, Change Requests) as required.
- Monitors Operations labor, projects and expenditures to ensure financial and site goals are met.
- May assist in developing budgets.
- Documents operations, planning, and logistics activities accurately and appropriately, and according to established formats. Writes and/or revises documents (e.g., SOPs, Variances, Rework Orders, Change Requests) timely and in compliance with cGMP/ QSR practices.
- Supervises day-to-day operations, coordinating the scheduling and execution of planning and logistics procedures. Defines and monitors project timelines, ensuring timely achievement of overall project goals and establishing priorities. Performs supervisory functions including performance management and career development guidance for direct reports. Responsible for providing appropriate training and development opportunities for staff.
- Participates in routine training activities to maintain/enhance own technical skill level and supervisory abilities.
- Participates in managing the schedule and work assignments for order management, planning and scheduling, operations information management as well as inventory management and control. Participates in or leads project-based activities (e.g., supply chain management, new product transfers, global information management) to support departmental goals. Maintains control of work group expenses within limits of DOA.
Formal Training/ Education
- Required: Bachelor's Degree- Bachelors in Biological/Life Sciences, Chemistry, Biochemistry or related field.
- Preferred: PHD
- Required: 8 years relevant industry experience.
- Preferred: 8+ years
- Equivalent combination of education and work experience.
Knowledge, Skills or Ability
- Experience in assay optimization, experimental design, versatile laboratory practice, data analysis, and data and concept presentation.
- FDA experience desired
- Experience in quality systems regulations
- Demonstrates basic understanding of other scientific disciplines
Roche is an equal opportunity employer
- 10% Based on Business needs
and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .