Supervisor, Quality Control-Analytical Testing (Onsite)

POSITION SUMMARY

The Quality Control Analytical Testing group supports the raw material bulk drug substance (API) drug product and in-process monitoring programs of the production facility and support areas. The group supports manufacturing activities at the Northpointe Facility through testing and release of finished drug product and the analysis and confirmation of the suitability of both the raw materials used in the manufacture of product and in-process materials generated during the different stages of the manufacturing process. The group routinely interacts with production engineering validation materials management procurement quality assurance and other QC groups.

PRIMARY RESPONSIBILITIES

Functional:

• 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 Organizations/Sites Life Cycle Management Plan.
• Leads by example and promotes PTxs 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.

People Leadership:

• 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 PTxs 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 PTxs 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.

KNOWLEDGE SKILLS ABILITIES

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.

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.

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• 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.

Preferred:

• 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.

EXPERIENCE & EDUCATION

Required:

• 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:

• Bachelors 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.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $92400 $122000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options annual cash bonuses 401k matching free parking or Seattle-area ORCA pass tuition assistance plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.