Senior Analyst I of Quality Control Cell Biology | Lexington, Massachusetts | Onsite

Title: Senior Analyst I of Quality Control Cell Biology

Location: Lexington, Massachusetts | Onsite

Duration: 6-12+ Months

MUST HAVE SKILLS;

• Specific Cell Biology Focus Areas:

• Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.

Additional Specific Experience:

• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Previous experience in a GMP QC role is preferred
• 5S/OE experience
• Method transfers
• Key Skills, Abilities, and Competencies
• Knowledge:
• Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.

Key Skills:

• MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding

Job Summary/Operations Involvement:

• Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies.
• Testing may include but not limited to samples from drug substance/product and various protocol studies using test methods derived from the various compendia and non-compendial sources.
• The position is expected to maintain operational and GMP readiness of the QC area.
• In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects.
• Position is expected to act as a role model for junior staff in the various QC areas.
• In addition, management, coaching, and mentoring of junior staff in the lab will be required.

Discretion/Latitude:

• Work is performed under general direction with little to no supervision.
• Participates in determining objectives of assignments.
• Plan schedules and arranges own activities in accomplishing objectives.
• Work may be reviewed upon completion for adequacy in meeting objectives.
• Exerts some influence on the overall objectives and long-range goals of the organization.
• Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.

Specific Cell Biology Focus Areas:

• Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.

** Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.

Specific QC Focus Area:

• Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays

Responsibilities: Job Function and Description

Job Scope

• Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which effect subordinate organizations.

• % of Time Job Function and description
• 40-50% Testing execution, participate in training analysts, trouble shooting of methods
• 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
• 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

Education and Experience Requirements;

• Typically requires a bachelor's degree and a minimum of 4+ years of related experience. (science related degree is preferred)

Additional Specific Experience:

• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Previous experience in a GMP QC role is preferred
• 5S/OE experience
• Method transfers
• Key Skills, Abilities, and Competencies
• Knowledge:
• Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.

Key Skills:

• MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding

Complexity and Problem Solving

• Develop solutions to a variety of complex problems. May refer to established precedents and policies. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.