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.

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

Regulatory Affairs Director / Senior Director / San Diego, California

Job Description
  • Oversees industry specific regulations, policies and procedures, and ensures all government and company regulations are being met, both in the USA and in other countries where product specific development, including clinical trials, is occurring.
  • Explains such regulations, policies and procedures to company personnel.
  • Ensures compliance with these regulations.
  • Advises others on regulatory and compliance matters.
  • Evaluates applicable laws and regulations to determine potential impact on the company.
  • Creates and implements regulatory strategies for planned BLA submissions.
  • Provides technical review of data and reports.
  • Leads d regulatory activities related to biologics license application (BLA)
  • Coordinates regulatory documentation activities.
  • Works closely with Clinical Affairs, Medical Affairs, and Manufacturing and Nonclincial colleagues to develop clinical/nonclinical, and CMC regulatory strategy.
  • May supervise Regulatory Affairs team members.
Education and Experience
  • Minimum requirement is a Bachelor’s Degree in science or healthcare. A PhD is preferred.
  • Successfully prepared and filed a BLA.
  • At least 10 years of Regulatory and/or Project Management experience.
Location
  • The successful candidate will already be in the San Diego area, or willing to relocate to San Diego. A portion of time may be spent telecommuting.

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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