Job Announcement

Job Announcement

Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer.
The company’s lead therapeutic, ADI-PEG 20, is a novel biologic in late-stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including mesothelioma, sarcoma, melanoma, acute myeloid leukemia and others.
We are seeking applicants for the positions listed below. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable and willing to take on additional responsibilities as required.

Senior Clinical Trial Manager / San Diego, California

Responsibilities:

  • Ensures the success of Polaris clinical trials through the selection of appropriate sites, executing successful investigator or advisory meetings, implementing effective recruitment strategies, and communicating with sites
  • Ensures that all trial deliverables are met according to timelines, budget, quality standards and operational procedures
  • Leads the study team in the development of clinical protocols, amendments, informed consents, CRF/ source document design, protocol specific training documentation, administrative letters, and other written clinical documents
  • Manages clinical trial outsourcing, including RFPs, and Bid Defense meetings, and assists in CRO selection
  • Manages CROs, vendors and internal staff, as required
  • Reviews CRO and contractor invoices
  • Trains and mentors new clinical trial staff with appropriate delegation
  • Manages clinical monitoring activities and may conduct monitoring visits or co-monitoring visits including source document verification, as required
  • Participates in data cleaning, listing, and coding report reviews
  • Uses project management tools, including project plans, timelines, and meetings to manage all aspects of the trial(s), including budgets
  • Monitors and tracks clinical study progress and provides status update reports
  • Responsible for implementation and oversight of Trial Master File for inspection readiness.
  • Participates in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections
  • May prepare interim/final clinical study reports
  • Contributes to the development of abstracts, presentations, and manuscripts
  • May develop or update SOPs and best practices and facilitate their implementation.

Requirements:

  • Bachelor’s degree or higher, preferably in science or healthcare
  • Minimum of 8 years in a clinical setting with at least 4 years of clinical research experience in the biotech/medical diagnostics/pharmaceutical industry or CRO
  • Oncology experience preferred
  • Experience in managing clinical studies and CROs
  • Flexibility and excellent organizational and interpersonal skills.
  • Excellent knowledge of Good Clinical Practice and International Conference on Harmonization guidelines
  • Excellent written and verbal communication skills

Clinical Scientist / San Diego, California

Responsibilities:

  • Contributes to clinical and pre-clinical program development strategy and execution
  • Analyzes and interprets study data, and prepares scientific reports and presentations
  • Contributes to and authors strategic documents including pre-clinical and clinical sections of regulatory documents such as Investigator’s Brochures, IND submission documents, study protocols, statistical analysis plans, responses to Health Authority questions
  • Contributes to study-related advisory boards and investigators’ meetings
  • Manages collaborations with external groups
  • Leads translational special interest projects
  • Contributes to the development of abstracts, presentations, and manuscripts
  • Assists with design, development and implementation of training programs for more junior colleagues
  • Assists with clinical site evaluation

Requirements:

    • Master’s degree or PhD in Life Sciences, or Pharm D or MD
    • Minimum of 3 years of experience in planning, executing, and reporting clinical studies in a biotech, pharmaceutical, or CRO environment
    • Knowledge of oncology pre-clinical and clinical drug development is desirable
    • Experience with U.S. and European regulatory authorities and submissions is preferred
    • Ability to produce clear written scientific communications and excellent verbal communication

Director, Manufacturing Science and Technology / Vacaville,California

ROLE SUMMARY

The Director of Manufacturing Science and Technology (MSAT), under minimal supervision, is responsible for developing a strategic vision and overseeing the MSAT group. The MSAT group is responsible for process development, process optimization, process scale-up, process transfer, manufacturing support, and process validation. This position will be required to communicate interdepartmentally in order to coordinate multiple activities related to MSAT and have the ability to take initiative without direct oversight. Thorough technical knowledge of biopharmaceutical manufacturing processes and associated equipment including fermentation, column chromatography, and tangential flow filtration are essential. The Director of MSAT is expected to act as a mentor for MSAT personnel.

ROLE RESPONSIBILITIES

  • Lead the MSAT group to achieve company objectives and goals.
  • Provide technical input and support to the manufacturing team. This includes support for deviation
    investigations, resolution strategies, corrective and preventative actions, and process improvements.
  • Provide support to the MSAT Engineer responsible for process validation of products in late-stage clinical trials
  • Oversee technology transfer of new products for the site.
  • Provide support to the MSAT Engineer responsible for process development and process optimization.
    Supervise the design and execution of experiments and the interpretation of results.
  • Provide solutions to complex biopharmaceutical manufacturing challenges.
  • Create and improve manufacturing process strategies while complying with cGMP regulations.
  • Obtain a strong understanding of the manufacturing process and equipment operation.
  • Develop and recommend manufacturing equipment and process improvements to support future business strategies.
  • Oversee the MSAT department budget.
  • Establish schedules and ensure resources are adequate to meet the demands of the MSAT schedule.
  • Develop and maintain a well-trained and efficient MSAT work force. Evaluate the performance of direct reports and provide regular performance feedback and mentoring.
  • Represent the MSAT department during internal or external audits, including FDA Pre-Approval Inspections.
  • Responsible for talent management (recruitment, development and retention) in the MSAT department.
  • Ensure a safe work environment for the MSAT group
  • Perform other company duties as required by Executive leadership.

SKILLS

  • Strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
  • Ability to perform responsibilities without supervision.
  • Thorough technical knowledge of biopharmaceutical manufacturing including microbial fermentation,
    protein purification, tangential flow filtration, and aseptic processing.
  • Proficiency in Windows, Microsoft Word, Excel, Microsoft Teams, or other organizational applications.
  • Good written, verbal, and communication skills.
  • Ability to coordinate interdepartmentally with Quality Control, Facilities, Manufacturing, and Quality
    Assurance for scheduling of MSAT related projects.

QUALIFICATIONS

  • BS/BA in Engineering/Science related field and at least 12 years of relevant experience is desired.
  • MS Degree in Engineering/Science related field and at least 10 years of relevant experience is desired.
  • PhD in Engineering/Science related field and at least 6 years of relevant experience is desired.

Director, Manufacturing / Vacaville, California

ROLE SUMMARY

The Director of Manufacturing is responsible for overseeing the manufacturing department, drug product manufacturing, and implementation of new drug products while complying with cGMP regulations. The Director of Manufacturing will maintain a department budget, guide production management on personnel/project development, and improve department organization. The Director of Manufacturing is expected to obtain a strong understanding of the manufacturing process and equipment, and other site quality systems. This position will be required to communicate interdepartmentally in order to coordinate multiple activities related to manufacturing, and have the ability to take initiative without direct oversight. Knowledge of processes including fermentation, column chromatography, and tangential flow filtration are highly desired. The Director of Manufacturing is expected to act a mentor for all manufacturing personnel, and as a lead during manufacturing audits.

ROLE RESPONSIBILITIES

  • Lead the manufacturing department to achieve company objectives and goals.
  • Oversee the manufacturing of drug products and implementation of new drug products.
  • Obtain a strong understanding of the manufacturing process and equipment operation.
  • Develop and recommend manufacturing equipment and process improvements to support future business strategies.
  • Oversee the manufacturing department budget.
  • Provide guidance and oversight of production management.
  • Provide input and management toward the master production schedule.
  • Mentor manufacturing personnel for career development.
  • Provide guidance and insight for deviation investigations, resolution strategies, CAPA implementation, and material review board decisions.
  • Communicate with vendors regarding raw materials or services.
  • Represent the manufacturing department during internal or external audits, including FDA Pre-Approval Inspections.
  • Perform other company duties as required by Executive leadership.

SKILLS

  • Performs tasks associated with maintaining cGMP compliant manufacturing department.
  • Ability to perform responsibilities without supervision.
  • Proficiency in Windows, Microsoft Word, Excel, Microsoft Teams, or other organizational applications.
  • Good written, verbal, and communication skills.
  • Ability to coordinate interdepartmentally with Quality Control, Facilities, MSATs, and Quality Assurance for scheduling of manufacturing related projects.

The Director of Manufacturing must develop the skills necessary to organize and lead the manufacturing department in order to achieve company objectives and goals. The Director of Manufacturing candidate is desired to have previous experience with manufacturing of recombinant protein therapeutics, managing direct reports, projects, and commercial manufacturing, and have participated in regulatory audits.

QUALIFICATIONS

  • At a minimum B.A/B.S., or M.S. in a science or engineering field with a minimum of 10 years of relevant work experience, or a combination of education and experience.

Director of Quality / Vacaville, California

ROLE SUMMARY

The Director of Quality is responsible for leading the Quality Team in maintaining all aspects of quality within a highly collaborative and cross-functional environment ensuring product quality, compliance and customer satisfaction for both in-house and CDMO products. The Director of Quality manages the Quality Assurance and Quality Control departments and is responsible for the following functions: release and stability testing; method validation; environmental monitoring program; CMC-related regulatory activities; raw material quarantine, inspection, sampling, testing, and release; lot release; deviations and CAPA; supplier management and internal audit programs; document and change control programs; training program; facility and utility quarantine and release; complaints and product returns; and drug product shipping. This individual will need to build systems/processes and organize resources to establish and achieve product release cycle time targets and meet project due dates/deliverables. Additionally, the Director of Quality will be responsible for establishing a scalable quality system to support the future growth of a multi-product GMP manufacturing facility, including PAI preparation and implementation of computerized quality systems.

ROLE RESPONSIBILITIES

  • Ensuring Polaris quality requirements are compliant with the appropriate regulations by various regulatory bodies/entities.
  • Approve or reject drug products for clinical and/or commercial distribution.
  • Approve or reject all procedures, specifications, validations, and changes impacting the regulatory commitments for Polaris products.
  • Provide guidance and overall business strategy to QA and QC personnel in maintaining the quality functions to support the master production schedule.
  • Partner with the Production and Facility departments to create and maintain the site Master Validation Plan.
  • Provide development opportunities for reporting staff and maintain overall training methodologies for all quality associates.
  • Responsible for hosting audits of Polaris by regulatory authorities, qualified persons, clients, and partners.
    Support audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations.
  • Ensure the Polaris external audit and internal audit programs meet current business strategies and objectives.
  • Management of raw material introduction, review, and release system for all materials used in drug manufacturing.
  • Responsible for the leadership of quality control functions including cGMP analytical method development,
    testing, validation, and routine QC laboratory operations.
  • Management of the product review and release system.
  • Management of Change Control and Document Control Systems.
  • Keep up to date of current Quality Standards and Regulations impacting the biopharmaceutical industry.
  • Responsible for organizing Quality Management Review and compiling and reporting on the performance of the quality system.
  • Develop and recommend quality system improvements to support future business strategies.
  • Oversee the development and maintenance of the stability program. Review stability data and stability reports, providing guidance where needed.
  • Oversee investigations for “systemic” quality events at the site, including resolution strategies, CAPA implementation, and Material Review Board decisions.
  • Provide leadership with respect to sample scheduling and daily process prioritization.
  • Holds self and others responsible to abide by department and company policies and practices.
  • Implement system improvements and procedural revisions, with emphasis on increasing laboratory efficiency, accuracy, and safety.
  • ttend all department meetings, support discussions and formulation of ideas for laboratory infrastructure improvements and method optimization.
  • Perform trend analysis/reports and critical thinking to the progression of the environmental monitoring programs, method validation, investigations, technical studies, and method transfer protocols.
  • Oversee site-related CMC activities.
  • Final sign-off on all product labels, package inserts and Marketing Material.
  • Determine the financial needs of the Quality departments to create and manage an annual budget that is consistent with strategic direction, division needs, and stakeholder expectations.

SKILLS AND EXPERIENCE

  • Ability to manage complex projects involving multiple functions
  • Ability to gain consensus on key quality/operational decisions
  • Strong analysis/problem solving skills
  • Strong attention to detail/quality focus
  • Balanced cost/quality/customer focus
  • Ability and willingness to provide leadership to the entire group, with proficiency in both facilitating active and open discussion, and laying groundwork for logical decision making.
  • Ability and willingness to collaborate with and influence other groups in a positive, team-based environment. Must also be able to hold others to account as required.
  • Work with a sense of urgency and have the ability to be impartial and objective.
  • Excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
  • Excellent organizational skills.
  • Be an active learner and developer of self and others.
  • In-depth knowledge of International Standards, GLP, and GMP
  • Experience with GMP, analytical, and environmental monitoring/analysis preferred.
  • Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
  • Experience in developing and delivering effective training on Quality Systems and Processes is preferred.

QUALIFICATIONS

  • B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). 8-12 years of relevant management experience in a biopharmaceutical quality field is desired.
  • MS Degree in Science/Related Field (major in biology-biochemistry-chemistry). 5-9 years of relevant management experience in a biopharmaceutical quality field is desired.
  • PhD in Science/Related Field (major in biology-biochemistry-chemistry). 3-6 years of relevant management experience in a biopharmaceutical quality field is desired.
Polaris Pharmaceuticals, Inc. does not discriminate in employment opportunities or practices based on race, color, gender, religion, veteran and military status, marital or registered domestic partner status, age, national origin or ancestry, disability, medical condition (including genetic information or characteristics), sexual orientation, or any other characteristic protected by federal, state, or local laws.
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