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Partner Therapeutics · 2 months ago

Supervisor, Quality Control-Analytical Testing (Onsite)

Lynnwood, Washington, United States

Full-time

Onsite

Senior Level

$92K/yr - $122K/yr

6+ years exp

Partner Therapeutics is a company focused on supporting manufacturing activities through quality control analytical testing. They are seeking a Supervisor for the Quality Control Analytical Testing group to oversee daily operations, ensure compliance with regulations, and lead a diverse team while fostering a culture of continuous improvement.

BiotechnologyHealth CareMedicalMedical DeviceTherapeutics

Comp. & Benefits

Responsibilities

Oversight of daily operations of QC PT/CB lab, supporting testing service needs for Manufacturing, Validation, Engineering & other Quality groups as needed

Supports safe, efficient, functional and compliant laboratories testing operations developed in accordance with site, corporate, and regulatory guidelines

Provides analytical expertise and support for product investigations, continuous improvements, etc. to ensure continued compliance with regulations

Develops and implements Quality Control laboratory systems that support metrics / data trending, management review, subcontractor qualification and audits for Leukine testing

Oversight of departmental training program

Oversight of departmental deviations/CAPA, change controls and laboratory investigations

Supports execution and continuous improvement for Drug Product, Bulk Drug Substance, In-Process and Raw Materials program(s)

Oversees sampling and laboratory testing execution ensuring timely results produced meet quality standards and requirements

Identifies and prioritizes implementation of opportunities to improve Quality processes and practices

Works collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner

Reviews emerging and updated regulations and guidelines, stays current on industry trends and develop and implement gap remediation strategies with guidance from QC Manager, as necessary

Reviews and audits documentation to ensure accuracy, specifications and GMP Compliance

Participates in the development and prioritization of the Organization’s/Site’s Life Cycle Management Plan

Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the quality culture at PTx

Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes

Successfully completes all mandatory Quality and Compliance training within required timeframes

Resolves “stuck” issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future

Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions

Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs

Provides leadership and direction to the QC-Analytical Testing team and support teams to ensure KPIs are consistently met while demonstrating and embodying PTx leadership values

Establishes individual goals and objectives in alignment with department goals and priorities

Identifies performance improvement targets and metrics. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets

Recommends and allocates resources - human, technical, etc. - to fulfill near term goals and commitments while building towards sustainable excellence

Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously improve

Works pro-actively and in close collaboration with upline Leadership Team and People & Culture to recruit, hire, grow, and retain a diverse team of talent

Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx’s core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx

Meets consistently with all Direct Reports in the GOOD 1:1 format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly

Through active leadership and coaching, while embracing PTx’s Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, and have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations

Pro-actively creates opportunities to develop their Team, including ensuring career paths have been developed for Partners (as needed), and enhances the Team through cross-training others, identifying competency gaps, etc

Qualification

QC laboratory testingGMP complianceProject managementAnalytical expertiseContinuous improvementRelationship managementTeam buildingTraining skillsLeadership skillsProblem-solving skillsCommunication skillsOrganizational skillsConflict resolutionActive listeningSoft skillsInterpersonal skills

Required

Effective scientific / technical knowledge with QC laboratory testing (e.g., wet chemistry assays, purity assays, and potency assays); Experience troubleshooting and investigating assay and equipment issues

Familiarity with USP and global compendial regulations

Skilled at managing projects with some oversight

Resourceful with proven ability to lead, manage and leverage an internal network of stakeholders and team members to plan and resolve issues. Strong relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members

Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward

Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget. Demonstrated ability to delegate successfully

Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges

Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations within own function. Skilled at leading effective meetings

Solid software skills essential including Word, Excel, PowerPoint, Outlook; ability and willingness to quickly adopt other job-specific applications will be necessary

Proven ability to lead teams and/or projects effectively and to ensure GMP compliance while operating in an evolving, complex and dynamic environment

Experience implementing continuous improvement projects

Demonstrated commitment to fostering the professional growth and development of others; this could include training others on specific technical skills, mentoring, participating in workgroups that enhance development of others, etc

Knowledge of standard interviewing protocols; recent experience participating in the hiring process as an interviewer or hiring manager

Strong leadership skills included a demonstrated ability to drive accountability and build a departmental culture of trust, compliance, efficiency, and continuous improvement

Proven ability to enhance engagement by driving an environment within which individuals and teams can excel and continuously improve

Skilled at active listening, conflict resolution, and team building

Interactive training in essential people skills

Highschool diploma or GED

6+ years progressively responsible, relevant experience in an FDA regulated environment required. BA/BS degree or equivalent in related field may substitute for 2 years of relevant professional experience

1+ years of experience in a People Leadership or “Lead” role. People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing high performers, and addressing performance concerns. “Lead” qualification includes time in a formal Lead role, and/or leading project teams, and/or collateral activity teams, and participating on interview panels over an equal period of time

Preferred

Practical understanding of principles of project management; formal project management training a plus

Recent experience with workforce planning

Software application experience with Smartsheet, MS Project, and SharePoint

Previous experience participating in internal and external audits and inspections, including providing subject matter expertise and direct responses to agency regulators

Formal interview training

Formal people leadership training including development of giving-and-receiving-feedback skills

Experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent

Bachelor's degree in Chemistry, Biochemistry, Biology, Cellular Biology or related scientific field

5+ years QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent