BioSpace · 2 days ago

Principal Scientist, Process Technical Operations

Ayer, MA

Full-time

Hybrid

Senior Level

8+ years exp

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Comp. & Benefits

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Responsibilities

Provide support to Upstream and Downstream Manufacturing for commercial biologic products manufactured in 24/7 operated manufacturing facilities: including stainless steel and single-use facilities.

Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements and robustness, and review and approval of change controls.

Evaluates process performance by comparing manufacturing data to historical data through univariate and multivariate techniques with recommendations generated for process enhancement.

Routinely liaises with MS&T Process Champions, and Devens MS&T lab functions regarding strategies for technical and operational improvements, investigation resolution, and process validation.

Supports aspects of process technology transfer, process validation and the preparation of CMC documentation for regulatory filings and responses for the BMS Devens commercial manufacturing facility through cross-functional leadership and individual technical contribution.

Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site.

Invests in the growth of the group, including current and future leadership, through assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition.

Establishes high performance standards, defines clear accountability, and leads by developing, adopting, and supporting continuous improvement.

Actively communicates group's activities and progress through varied technical and non-technical forums.

Qualification

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BioprocessingSOPsCGMPsRegulatory ComplianceProject ManagementMentoringProblem-SolvingInterpersonal SkillsLeadershipCommunicationTeamworkBiologics Manufacturing ProcessesUnivariate Data AnalysisMultivariate Data AnalysisDiscoverantJMPSeeqSIMCA-online

Required

Knowledge of engineering and science attained through studies resulting in a BS (>8 years)/MS (>6 years)/PhD (>4 years) in Chemical or Biochemical Engineering, or its equivalent.

Expertise in upstream and downstream drug-substance bioprocessing is required.

Familiarity of SOPs, cGMPs and the know how to work and manage within a regulatory environment.

Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties.

Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams.

Experience in working in / leading cross-functional teams is essential.

Demonstrated problem-solving ability, interpersonal, and oral and written communication skills are essential along with strong leadership skills.

Strong work ethic and ability to mentor junior staff.