CAREERS

Join us in developing pioneering therapies that will transform the medical landscape and change patients’ lives. Our technology regenerates diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Director, Quality Assurance

The Director, Quality Assurance will be responsible for leadership of a functional team as well as individual contributions to establish quality operations for ProKidney located in Winston Salem NC. This role will manage and execute GMP quality assurance activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Essential Duties and Responsibilities:

· Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition

· Oversight of Aseptic processing, environmental monitoring program, and technical transfers between development/GMP including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations

· Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions

· Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing

· QA oversight of equipment/facility/utility validation and requalification program and validation master plan

· Review protocols, data summaries, reports for stability studies

· Ensure compliance with current U.S. and EU cGMP regulations and industry standards

· Manage the inspection readiness program at the site to ensure site is always inspection ready and manage the logistics of any corporate, external or Health authority inspections at the site

· Manage the internal and external audit program

· Facilitate the site quality council, providing timely and metric driven updates on the status of quality systems for management reviews and other leadership forums

· Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction

· Provide input for continuous improvement of corporate quality systems

· Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy

· Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner

· Perform risk assessments of new programs for entry into the GMP facility

· Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends

· Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role

· Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems

· Ensures quality staff assesses and approves change controls

· Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.

· Establish, educate, and enforce standard operating procedures required under GMP.

· Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.

· Identify performance or compliance gaps and implement or propose solutions; solve complex problems of a technical nature.

· Maintain a state of readiness for and participate in audits and inspections.

· Manage complexities within a product development environment to plan, organize, execute, monitor staff assignments and all activities necessary to achieve continuous clinical supply.

Education level and/or relevant experience required:

Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy Manufacturing

Knowledge and skills (general and technical) preferred:

· Quality Assurance experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility

· Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required

· Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams

· Knowledge of GMP, GCP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy productsDenonstrated ability to lead on-site corporate, external or Health authority inspections.

· Strong knowledge of current industry trends and the ability to use the latest technologies

· Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.

· Strong leadership skills with the ability to thrive in a high throughput environment

· Ability to lead and manage projects/teams within corporate objectives and project timelines

· Successful in mentoring people managers

· Collaboration / Teamwork / Conflict Management

Preferred Experience and Skills:

· Biologic or cell therapy manufacturing and/or analytical testing

· A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.

· Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.

· Ability to identify, focus, and solve problems in a timely and efficient manner.

· Experience with quality audits and EU regulatory inspections.

· Experience or working knowledge of R&D or clinical supply areas and processes

Qualified,interested candidates should send resume to: careers5@prokidney.com

Associate Director of Quality Control

The Associate Director, Quality Control will be responsible for leadership of a functional team as well as individual contributions to establish quality control operations for ProKidney located in Winston Salem NC. This role will manage and execute GMP quality control activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Primary Responsibilities and Job Functions:

  • Developing/qualifying/validating analytical methods based on experience, first principles, sound theory, etc.
  • Manage/coordinate/drive efforts of staff in conjunction with approved plant scheduling; ensure adherence to agreed-upon deadlines; timely completion of work.
  • Assure compliant, staffed analytical laboratory support.
  • Recommend/justify new/additional equipment, upstaffing or organizational positions, promotions.
  • Develop/maintain/improve Analytical Procedures/SOPs/systems/procedures/similar.
  • Ensure training, development, and mentoring of laboratory colleagues.
  • Represent GMP Analytical in production meetings, customer discussions, etc.
  • Design, develop, conduct and/or review experiments including method qualification/validation, method transfer, and unknown identification utilizing typical instrumentation including but not limited to LC, MS, GC, etc.
  • Use/facility in various instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-instrumental methods (wet chemical methods)
  • Write reports documenting outcomes of experiments/exercises.
  • Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance)
  • Act as scientific, regulatory, technical or quality expert/liaison in team meetings and other settings by providing timely input to project activities/support to customers, responding to targeted questions, etc.
  • Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
  • Prepare samples for analysis and record data from analyses or experiments in a computer, logbook, or laboratory notebook.
  • Perform data audits in order to ensure accuracy of data and analytical processes.
  • Provide leadership including cross-training and technical development to other laboratory colleagues as needed.
  • Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
  • Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
  • Demonstrate insight in design of experiments and gathering/interpreting data in order to deduce and/or test mechanistic or systematic hypotheses.

Education level and/or relevant experience required:

  • Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

Knowledge and skills (general and technical) preferred:

  • Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Preferred Experience and Skills:

  • Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
  • Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
  • Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Qualified,interested candidates should send resume to: careers5@prokidney.com

Materials Handler I

Department:     Operations Resource Management

Report to:           Associate Director, Supply Chain and Material Management

Status:                Full Time

Primary Responsibilities and Job Functions:

  • Execute material receiving function.  Reconciling purchase order with received materials.
  • Responsible for GMP compliant receiving, visual inspection, labeling, inventory transactions and records.
  • Execute GMP put way of material.  Execute proper cabinet or cold storage requirements
  • Issue from stores to MFG via material transfer staging rooms upon request from manufacturing personnel
  • Handle materials, including biohazardous materials and chemicals, stored at different temperatures (e.g.  -80C, -20C, 5C)
  • Ensure all inventory transactions are processed in a timely manner.
  • Demonstrate a great attention to detail in all transactions
  • Assist in maintaining material inventory, inform manufacturing and purchasing personnel of requirements base on expiry and low inventory
  • Assure all W/H materials are issued following the FEFO GMP methodology
  • Assure all materials are properly identified with corresponding lot, expiration date, serial, and part numbers
  • Operate computer and scanner to record transactional data entry and retrieval
  • Cycle count inventory, correct discrepancies. Track and report findings
  • Make CI recommendations for policies and procedures to improve quality, cycle time, and process flows.
  • Process courier sample shipments
  • Execute shipments through FedEx, UPS, or other dedicated couriers or logistics providers.

Secondary Responsibilities and Functions:

  • Keep dock and receiving area clean and organized in a perpetual state of audit readiness
  • Maintain outgoing shipping supplies
  • Assure compliance with company SOPs and policies.
  • Properly handle disposal of receiving/shipping waste and of all boxed biohazardous waste
  • Attend departmental/company team meetings as necessary.
  • Adhere to all training requirements
  • Perform tactical and other duties as assigned.

Requirements:

RequirementsDescription
Education/TrainingHigh School Degree or equivalent
LicensesNone
Experience1 year minimum of practical experience working in warehouse operations or equivalent.
Skills/AbilitiesPhysical ability to move material containers weighing up to 50 pounds. Ability to operate pallet jack and dock leveler.
OtherGood communication skills, both verbal and written Good computer skills

Qualified,interested candidates should send resume to: careers4@prokidney.com

QC Analyst I

Department:      Quality Control

Report to:           QC Manager

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will be responsible for performing routine quality control testing utilizing various biological and general laboratory techniques according to cGMP regulations. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills with minimal supervision are essential for success.

Requirements:

  • BS degree in the biological sciences or related field
  • 0-2 years relevant laboratory experience in a cGMP/FDA regulated industry
  • Demonstrated knowledge in the following laboratory techniques
    • Pipetting skills
    • Laboratory knowledge
    • Aseptic Techniques
  • Detail-oriented with strong written and verbal communication skills
  • Ability to problem-solve and troubleshoot as necessary

Qualified,interested candidates should send resume to: careers1@prokidney.com

Manufacturing Specialist

Department:      Manufacturing

Report to:           Manufacturing Manager

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will perform cell culture techniques, support mammalian cell culture manufacturing processes, operate various process equipment, and document daily manufacturing operations in a cGMP environment. Candidate will produce products by setting-up, cleaning, performing cell culture and following aseptic procedures. Additionally, the successful candidate will be responsible for maintaining a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures.

Requirements:

  • AS/BS degree in biological sciences or related field
  • 0-2 years relevant cGMP biotechnology/pharmaceutical production experience
  • Demonstrated knowledge in the following laboratory techniques
    • Cell Culture
    • Aseptic Technique
    • Sterile Gowning
  • Experience following SOPs and execution of batch records
  • Computer skills including email, word and excel
  • Excellent attention to detail

Qualified, interested candidates should send resume to: careers2@prokidney.com

QA Specialist I

Department:      Quality Assurance

Reports to:         Head of Quality

Status:                 Full Time/ Exempt

Position Summary:

The successful candidate will be responsible for implementing, tracking and monitoring company quality standards, procedures, systems and product manufacturing to ensure regulatory compliance.  The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of quality requirements for a regulated industry.   In addition, effective communication and teamwork skills with minimal supervision are essential for success.

Requirements:

  • BS degree in the biological sciences or related field
  • 0-2 years relevant quality experience in a regulated industry
  • Detail-oriented with strong written and verbal communication skills
  • Ability to problem-solve and troubleshoot as necessary

Qualified,interested candidates should send resume to: careers3@prokidney.com

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