Specialist/Sr. Specialist, Quality Assurance Batch Record Review

Specialist/Sr. Specialist, Quality Assurance Batch Record Review

Position Summary:

The Specialist/Sr.  Specialist Quality Assurance Batch Record Review will partner with Manufacturing in the development and approval of Master Batch Records (MBR).  This position will also provide Quality reviews of and disposition of Executed Batch Records (EBR) and associated supporting documentation for the production of clinical products.  Additionally, this position will support any other GMP documentation reviews required for QA Batch Release.

 
The Specialist/Senior Specialist Quality Assurance Batch Record Review supports the drug product manufacturing process with the following responsibilities:

  • Responsible for the development/review/approval of MBRs
  • Responsible for the review and approval of EBRs
  • Work with internal manufacturing or CMOs as necessary to address any comments or corrections identified during the EBR review process
  • Confirm all deviations and investigation reports are closed prior to approval of EBRs
  • Collect and organize all required manufacturing documentation necessary for release of DS/DP
  • Maintain a batch record review schedule to ensure on-time product disposition

Minimum Education/Experience: 

  • Bachelor’s degree (or equivalent), preferably in scientific discipline or a health-related field and at least 2 years of experience reviewing Batch Documentation in the Pharmaceutical industry
  • Working knowledge of FDA and EMA GMP regulation and ICH guidance documents
  • Experience in the manufacture of biopharmaceutical drug substance and drug products.

Other Qualifications:

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)

Sr. Logistics Specialist

Sr. Logistics Specialist

Position Summary:

Under the direction of the Manager of Warehouse & Logistics, the Sr. Logistics Specialist is responsible for leading the daily operations of warehouse activities for the Pleasanton Manufacturing Facility, ensuring operations are compliant with cGMP’s and safety guidelines. Responsibilities include the receipt, storage, inventory management, and distribution of cGMP/Non GMP materials, samples, supplies and equipment. 


The Sr. Logistics Specialist ensures all activities within span of control meet or exceeds Gritstone Oncology’s standards and meet full compliance of all applicable regulatory governing (e.g., FDA, EU, USDA, DEA, and DOT, etc.). In addition, this position is accountable for ensuring safe, cost-effective, and efficient warehouse and supply operations.  
This role will lead the daily operations of all shipping & receiving including cGMP receipt and distribution activities. Hands on and direct support across functions is necessary as set forth by the Warehouse Manager. 


This position will assist in the creation of procedures, plans and documentation as associated with the Warehouse & Logistics functions.  
 

Summary of Essential Job Functions: 

  • Perform administrative and/or physical tasks involved in the shipping, receiving, storage, and distribution of GMP/Non-GMP materials, samples, supplies and equipment
  • Support the implementation of departmental operations, strategies, policies and procedures in accordance with all applicable governing bodies including but not limited to FDA, EU, USDA, DOT, CBP, OSHA, and in alignment with all Company policies, procedures, goals and objectives
  • Perform all activities of the logistics and warehouse functions to enable a compliant cGMP manufacturing site.  Implement and administer all systems and processes for maintaining control of 1) inventory and transaction accuracy, 2) warehouse and controlled temperature storage methods and facilities, and 3) domestic and international transportation programs, housekeeping, pest control and GMP compliance
  • Maintain appropriate training to properly perform job associated roles/responsibilities and operate in a safe and compliant manner
  • Write and review reports upon request. Perform, document and review change controls and investigations within area of responsibility

 

Requirements:

  • High school diploma or equivalent
  • Requires formal training in supply chain management, logistics, or closely related discipline
  • Requires a minimum of five (5) years’ experience that includes: in-depth understanding of cGMP logistics operations, purchasing and inventory management in the Pharma/Biotech field or relevant field
  • Must possess a minimum of three (3) years supervisory or management experience.
  • Cold Chain experience required
  • Strong knowledge of Quality System Process: CAPA, Deviations, Change Controls required
  • Experience managing critical and complex projects
  • Must possess excellent attention to detail and analytical thinking
  • Strong goal-setting, team leadership, mentoring and professional development skills required
  • Strong ability to influence in a team environment and collaborate with peers
  • Must have a working knowledge of Trade Compliance responsibilities, on both the import and export sides of the logistics business
  • Must have excellent technical writing ability, oral and written communication skills
  • Experience / ability to understand and develop procedures and other controlled documents
  • Strong knowledge and understanding of software packages and technologies used in a typical logistics operation, specifically Microsoft Office
  • 3PL experience
  • Working experience and knowledge of applicable regulatory requirements (FDA, EU, FAA, IATA, DOT, Customs, and OSHA)
  • Performs other duties as required
  • Must be able to obtain Forklift Certification within 12 months of hire
  • Must be able to occasionally lift, up to 50 lbs
  • Must be able to push and pull up to 125 lbs. with a pallet jack
  • Must be able to climb a ladder and stairs
  • Some travel between Company sites may be required

Clinical Lab Technologist / Senior Clinical Lab Technologist

Clinical Lab Technologist / Senior Clinical Lab Technologist

The primary role of the clinical lab / senior clinical lab technologist is to be responsible for the execution of established nucleic acid extraction and next-generation sequencing (NGS)-based cancer genomics workflows including exome and transcriptome sequencing in a GMP environment.  The ideal candidate will have experience in a regulated environment (CLIA/CAP, GMP) and will be expected to maintain batch record reports, consumable inventory, equipment maintenance and calibration to maintain quality control and compliance.              

Minimum Education/Experience

  • Bachelor’s degree (or equivalent) in scientific discipline or a health-related field.

  • 3+ years relevant industry experience, including in a regulated setting

Other Qualifications

  • Strong background in molecular biology or biochemistry and associated general laboratory techniques (PCR, qPCR, nucleic acid purification)

  • Histology experience (microtome operation, FFPE sectioning and H&E staining) 

  • Familiarity with NGS workflows including nucleic acid extraction from various tissue specimens (cell line, blood, fresh frozen and FFPE), Illumina-based library construction, and hybrid capture enrichment 

  • Operation and maintenance of instrumentation critical for Illumina NGS workflows (qPCR, plate readers and HiSeq/MiSeq sequencers)

  • Strong experience with NGS workflow automation

  • LIMS experience
  • CLIA/CAP or cGMP experience

  • Experience working with Quality Assurance and Quality Control teams

  • Experience working in a controlled laboratory environment 

  • Impeccable documentation practices and attention to detail

  • The ability to prioritize and complete tasks in a timely manner

  • Excellent written and verbal communication skills.

  • A willingness to work hard in a fast-paced environment

Senior Manager/Associate Director, Regulatory Affairs CMC

Senior Manager/Associate Director, Regulatory Affairs CMC

Position Summary:

The primary role of this position is to provide regulatory CMC advice and direction, including the interpretation and application of global CMC regulations and guidance, to facilitate the development of products from early phase clinical trials through to worldwide submission and approval.

Specific responsibilities include:

  • Participation in or leadership of cross-functional subteams, development of regulatory strategies, and support for oncology development programs
  • Preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, meeting packages, etc.), to ensure timelines are met
  • Preparation of technical assessments of CMC source documentation and responses to technical questions on document content
  • Initiation and and/or contribution to local process improvements which have an impact on Regulatory Affairs or other departments
  • Involvement in preparation for and support of CMC interactions with regulatory health authorities

Requirements:

Minimum Education/Experience

  • Bachelor’s or Master’s degree (or equivalent) in life sciences
  • 5+ years of experience in regulatory affairs or related function within a biotechnology company
  • Direct experience managing regulatory CMC aspects of investigational biologic products essential, prefer experience with both mammalian and bacterial-derived products including vaccines, gene or cell therapy products


Qualifications

  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with all levels of management and contract manufacturing organizations
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
  • Strong knowledge of cGMP for biologic products, understanding of biopharmaceutical development, and CMC regulatory affairs
  • Self-motivated, self-disciplined, and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze and propose solutions to problems
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document management systems)

 

Scientist, Antibody Discovery

Scientist, Antibody Discovery

Position Summary:

The Scientist will support preclinical projects related to antibody discovery and development with the goal of developing novel cancer immunotherapies.  The successful candidate will contribute to the generation of novel antibody therapeutics and the characterization of such therapeutics in cell based and biochemical assays.

Requirements:

Minimum Education/Experience

  • PhD in Molecular Biology, Immunology, or a related field with ≥2 years post-PhD experience, including industry experience. Alternatively, BS or MS in Molecular Biology, Immunology, or a related field with >5 years experience in industry research.
  • Strong background in molecular biology, immunology and/or oncology with experience in antibody drug discovery and development.
  • Strong background in assay development to support antibody research programs for the development of immunotherapeutics.
  • A strong record of significant achievements in research and scientific creativity as evidenced by core contributions to publications.

Qualifications

  • Demonstrated experience in the evaluation of biotherapeutics from discovery to lead optimization.
  • Technical expertise with characterization of engineered proteins through biochemical and in vitro cell based assays.
  • Highly agile with strong organizational and interpersonal skills, demonstrated ability to work in a fast pace, highly collaborative environment with ability to multi-task.
  • Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and coaching junior team members.
  • Strong “can do” startup mentality and motivation.

Senior Scientist, Antibody Discovery and Engineering

Senior Scientist, Antibody Discovery and Engineering

Position Summary:

The Senior Scientist will be supporting preclinical projects related to antibody discovery and development, and will perform antibody design, engineering, production, and biochemical/biophysical characterization, and will establish in vitro (cell-based) assays for the evaluation of cancer immunotherapies.

Requirements

Minimum Education/Experience:

  • PhD in Molecular Biology, Immunology, or a related field with ≥4 years post-PhD experience, including industry experience. 

  • Strong background in molecular biology, immunology and/or oncology with experience in antibody drug discovery, development and/or antibody engineering for the development of immunotherapeutics.

  • A strong record of significant achievements in research and scientific creativity as evidenced by core contributions to publications.

  • Project and CRO management experience is highly desirable.
     

Qualifications:

  • Demonstrated experience in the design and evaluation of biotherapeutics from discovery to lead optimization.

  • Technical expertise with characterization of engineered proteins through biophysical assays and in vitro cell based assays.

  • Highly agile with strong organizational and interpersonal skills, demonstrated ability to work in a fast pace, highly collaborative environment with ability to multi-task.

  • Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and coaching junior team members.

  • Intense “can do” startup mentality and motivation.

 

Scientist/Senior Scientist, Molecular Immunology

Scientist/Senior Scientist, Molecular Immunology

Role

Reporting to VP, Immunology, the Scientist will be responsible for designing, performing and analyzing experiments in the field of immunology. We are looking for an independent and flexible team player who will thrive in a high-paced dynamic environment. 

Specific Responsibilities

  • Design and perform assays to characterize T cell responses, including but not limited to TCR analysis, transcription analyses, transduction and transfection of primary immune cells, flow cytometry and cell sorting
  • Cell culture, including primary human T cell cultures, development and maintenance of cell lines
  • Manage patient samples & maintain experimental records in electronic lab notebook
  • Assist with general laboratory duties including lab equipment maintenance, ordering and receiving of lab supplies

 Essential Requirements

  • PhD in molecular or cellular immunology, at least 2 years post PhD experience in the field of immunology. Hands on expertise in methodologies, reagents and instrumentation used for culture and characterization of primary T lymphocytes,  molecular cloning techniques,  generation of retroviral and lentiviral vectors.
  • High level of initiative, motivation and willingness to participate in a fast-paced work environment.

Preferred Qualifications

  • Experience with primary T cells and assays is highly preferred
  • Experience in cell sorting (single cell and bulk) is a plus
  • Highly organized with excellent record keeping skills
  • Focus on delivery of stable, reliable solutions
  • Ability to prioritize and complete tasks and advance projects
  • Ability to interact adaptably with scientists and non-scientists from various disciplines

 

Manufacturing Associate I/II

Manufacturing Associate I/II

Position Summary:

Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics. The company’s initial goal is to identify and deploy therapeutic neo-antigens from individual patients’ tumors to develop novel treatments for lung cancer.

The Manufacturing Associate will execute activities associated with manufacturing, as well as, development, optimization and qualification/validation in support of all Gritstone drug product manufacturing processes. Processes will vary in substance and composition, but will initially be focused on viral vector and nucleic acid based cancer vaccine products. This role will need to liaise with research, process development and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups. 

Summary of Essential Job Functions: 

  • Responsible for day to day manufacturing activities including stocking of materials, preparation of documentation, cleaning and sanitization of rooms and equipment, operation of process equipment
  • Stock production area with supplies
  • Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day
  • Execute process steps according to defined SOPs and batch records
  • Document activities in accordance with cGMPs
  • Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation
  • Maintain cleanliness and orderliness of operational area
  • Actively contribute to successful development, qualification and execution of robust manufacturing processes in support of company pipeline projects
  • Identify process and quality problems and follow corrective actions
  • Demonstrate knowledge and understanding of GMPs and how they apply to specific responsibilities
  • Maintain a safe working environment
  • Follow company policies and procedures

Requirements:

The successful candidate for this position will have demonstrated in-depth experience with GMP production. In addition, the candidate should have the following education/experience;

  • BS in Biological Sciences or related scientific discipline
  • 0 - 2 years or more in a cGMP manufacturing environment
  • Knowledge of GMP and regulatory requirements preferred

Other Qualifications:

  • Ability to lift items up to 35 lbs
  • Manual dexterity
  • Strong organizational skills and attention to detail, able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strong critical and logical thinking with ability to analyze problems
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)

Manufacturing Supervisor

Manufacturing Supervisor

Position Summary:

Reporting to the Director of Manufacturing, the Manufacturing Supervisor will initially work closely with the Process Development department to assist and/or lead select process development efforts.  In parallel, the Manufacturing Supervisor will assist in start-up activities at a manufacturing plant being built.  Some support of management of Contract Manufacturing Organizations (CMOs), including serving as Person-In-Plant will be required.  The role will transition fully to a cGMP manufacturing role as the process matures. 

This role will need to liaise with research, development, and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups.  This role will manage daily operations of cGMP manufacturing and include hiring of staff and development of cGMP procedures and policies.  Hands on and direct lab/cleanroom work is an expectation.

  • Possess experience and expertise in cGMP manufacturing environment. 
  • Possess experience and subject matter expertise in vector production –cell culture, purification, formulation, and fill. 
  • Experience in mRNA and Lipid Nanoparticle therapeutic vaccines a plus. 
  • Experience in supply chain management a plus.
  • Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day. 
  • Serve as Person-In-Plant at Contract Manufacturing Organization (CMO) when required.
  • Author SOPs, batch records, and review Validation Reports. 
  • Author deviations, change controls, CAPAs, and reports; possess understanding of quality systems.
  • Support process development and optimization activities independently or with minimal guidance.
  • Schedule production and coordinate/order/track/inventory raw material needs. 
  • Directly supervise staff in cGMP manufacturing within cleanroom.
  • Hire, lead, train, and mentor staff.

Requirements:

  • B.S. in Life Sciences, Chemical Engineering, or Biology
  • 5 years or more industry experience at pharmaceutical or biotechnology company
  • 3 years or more in a cGMP environment
  • 2 years or more in a supervisory position

Other Qualifications:

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
  • Up to 10% travel required, some international

Senior Quality Control Specialist

Senior Quality Control Specialist

Position Summary:

The primary role of the Senior QC Specialist is to transfer analytical methods from development to Quality Control and conduct cGMP analytical testing for raw materials, in process samples, finished product and stability testing per standard operating procedures. This role will work closely with the QC analyst and the Development group leading the transfer and implementation of analytical methods in Quality Control. This includes but is not limited to the following:

  • Transfer and implementation of analytical methods
  • Develop and implement QC Systems
  • Write and revise procedures
  • Implement new equipment, perform routine maintenance and troubleshoot equipment issues
  • Routine and non-routine testing which includes HPLC, viral assays, bioassays, cell based assays, qPCR and other analytical methods
  • Data analysis, statistical analysis, data management and documentation utilizing GDP  
  • Troubleshoot analytical issues, perform failure investigations, determine and implement corrective actions
  • Provide leadership and training in the lab to junior analyst(s)
  • Completing and reviewing cGMP documentation

Requirements:

  • Bachelor’s degree (or equivalent) in a scientific discipline with 10+ years relevant industry experience; MS in a scientific discipline with 8+ years relevant industry experience; Ph. D with 6+ years of relevant industry experience. 
  • cGMP experience required
  • Bioassay, viral assay and molecular biology (qPCR) proficiency Analytical method transfer and validation experience

Qualifications:

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)