Apply on Employer Site

Exact Sciences · 19 hours ago

Senior Production Scientist

US - WI - Madison

Full-time

Onsite

Senior Level, Lead/Staff

$91K/yr - $155K/yr

8+ years exp

Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Senior Production Scientist will lead projects to enhance efficiency within the Production department and oversee the operator training program while ensuring compliance with cGMP guidelines.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

Lead in the continuous development, refinement and oversight of the operator certification program

Manage or lead simple to complex process improvement and new product implementation projects

Perform classroom, on-the-job training and instructor qualification of Production staff

Effectively communicate with multi-level personnel as well as outside vendors and their representatives

Assist in maintaining the production schedule

Work on several varied projects at one time, with frequently changing priorities

Work effectively in team situations as well as independently

Prioritize tasks and adhere to project schedules and timelines

Ability to thrive in a fast-paced, frequently changing, and evolving environment

Review, update and develop SOPs, workflows, and training programs related to Production processes

Keep all documentation policies and procedures up to date to meet the Quality Manual System (QMS) and regulatory requirements

Provide in and out of lab leadership, as a technical expert, for all personnel within the Production team to ensure the successful, effective, efficient, and safe preparation of quality finished goods

Act as Subject Matter Expert (SME) on core functions of the Production organization (e.g., reagent manufacturing, product finishing, new product implementation, and process improvement)

Lead complex investigations, deviations, non-conformances, and CAPAs as they relate to production activities

Develop performance metrics and productivity metrics to drive process improvements and ensure visibility to leadership and team

Lead continuous improvement efforts or Kaizen projects to maintain or improve laboratory support processes and lab spaces, such as 5S and Lean Manufacturing efforts

Represent Production in routine cross-functional team settings (e.g., Material Review Board) or on project-based teams

Lead or assist in developing, transferring, scaling, and validating manufacturing processes, including formulation, filling, labeling, and packaging, in accordance with company procedures, cGMPs, FDA, and ISO 13485 guidelines

Extensive analytical and problem-solving skills; ability to make decisions with limited information and operate with autonomy

Strong communication skills; ability to influence and coordinate work with Production and other functional area leadership

Strong business acumen and strategic agility driving innovative solutions and new ideas forward

Ability to influence others, deliver on team vision, and hold partners accountable to timelines

Ability to accurately follow procedures with minimal direction

Ability to communicate clearly to other departments, as necessary, to drive alignment and visibility

Extensive documentation, attention-to-detail, and procedure writing skills suitable for a cGMP environment

Excellent oral and written communication and strong interpersonal skills

Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

Regular and reliable attendance

Ability to lift up to 40 pounds for approximately 10% of a typical working day

Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day

Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day

Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height

Ability to comply with any applicable personal protective equipment requirements

Ability to use various types of laboratory equipment including overhead mixers, scales, automated filling equipment, and pipettes for extended periods of time

May perform repetitious actions using lab tools

Ability to use near vision to view samples at close range

May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation

Ability and means to travel between Madison locations

Ability to travel 5% of working time away from work location, may include overnight/weekend travel

Qualification

CGMP knowledgeContinuous ImprovementSubject Matter ExpertProject ManagementFDA regulationsISO 13485 knowledgeMicrosoft Office SuiteAnalytical skillsBusiness acumenStrategic agilityCommunication skillsInterpersonal skillsAttention to detailTeamworkLeadershipProblem-solvingDocumentation skills

Required

Bachelor's degree in Life Sciences; or related field or the equivalent combination of education and experience

8+ years of experience in a manufacturing or life sciences environment

3+ years of experience in an FDA regulated 21 CFR 820 and/or ISO 13485 environment or equivalent

1+ years of experience leading projects or business initiatives and driving results

Experience as a subject matter expert on cGMP/IVD product manufacturing processes

Experience communicating and documenting complex subjects for distribution to a wide audience

Proficient in Microsoft Office Suite, internet navigation, and email usage

Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Applicants must be currently authorized to work in country where work will be performed on a full time or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time

Preferred

5+ years of leadership experience in a manufacturing environment

Strong knowledge in basic and advanced continuous improvement methodologies/principles, such as LEAN Six Sigma and/or Practical Process Improvements (PPI)

Experience with Project Management principles and practice

Experience in a biotech manufacturing environment

Experience with ERP systems, such as SAP