Principal Scientist Operations

Job description

·  Job facts

Job Description Summary
Conducts engineering studies for equipment cleaning, acts as a subject matter expert for cleaning and other manufacturing processes, and participates in investigations of aberrant cleaning results for equipment used to manufacture the liquid reagent components (e.g. enzymes, fermentation products, oligonucleotides, proteins, buffer solutions) of molecular diagnostic kits. Chairs meetings with multi-discipline input to perform risk analysis of new product manufacturing procedures and changes to manufacturing processes. Monitors the effectiveness of procedures used to clean manufacturing equipment, maintains the cleaning validation laboratory and required supplies, oversees cleaning monitoring program, and writes validation protocols/reports.

Job Summary – Responsibilities

·  Participates and leads project planning, production scheduling, process updates, and experimental design. Assumes responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities.
·  Designs experiments to test hypotheses related to project outcomes, and analyzes and interprets data/results. Recommends new or creative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility.
·  Conceives, plans and conducts independent production work or project work, defining schedules and applying advanced scientific knowledge to complete projects.
·  Assesses existing manufacturing and cleaning processes and identifies improvements for implementation with minimal guidance.
·  Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations (including QSR and FDA regulations). Interacts and collaborates with other departments to further project goals.
·  Accurately and consistently records experimental methods, materials and results in production records, hard copy notebooks and/or electronic laboratory notebooks. Analyzes data, evaluates results, forms conclusions, and determines future experiments. Works on diverse problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies.
·  Presents findings or comprehensive project status reviews at internal seminars/meetings. Applies advanced technical writing skills to produce reports, investigations and documents. Prepares summaries, internal reports, presentations, manuscripts, etc.
·  Serves as an expert resource to other departments (e.g., Manufacturing/Operations, Development, Quality, Marketing, Regulatory Affairs, Clinical Studies, and International Technical Services), provides timely response and follow-ups.
·  Participates in the expeditious transfer of products and technologies by providing scientific knowledge and assistance. May lead investigations of non-conformances. Provides technical advice/guidance to junior scientific staff, leads project teams to solve business problems of moderate size risk and complexity and serves as an overall role model.
·  Prepares and reviews validation documents for equipment cleaning procedures, as well as for manufacturing, filling and testing processes.
·  Conducts validation periodic review for previously completed process and test method validation, as well as routine monitoring of cleaning processes (includes sampling and testing of production equipment).
·  May manage a project budget, but generally budget oversight belongs to a higher level manager.
·  May represent RMD as primary contact on projects.
·  Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects and interacts with senior personnel from other RMD departments or Roche companies on matters often requiring coordination between departments/organizations.
·  Positions with people management responsibility have full HR responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selections, performance feedback, discipline, pay decisions and handling employee grievances/complaints.

Qualifications
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

Formal Training/Education - Education Level
Required: Bachelors in Chemical or Biochemical Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field.
Preferred: Master's Degree or Ph.D.

Experience
Required: 6 years' relevant industry experience.
Preferred: 7 + years of relevant industry experience.

Are equivalencies acceptable?
Yes - Equivalent combination of education and work experience

Knowledge, Skills and Abilities
Experience in cGMP manufacturing processes including cleaning, fermentation, column purification, tangential flow filtration, centrifugation, experimental design, aseptic processing, versatile laboratory practice, data analysis, and data and concept presentation.

Travel Requirements
10% Based on business needs

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer 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.