Aduro is a dynamic, fast-paced company on the cutting edge of immunotherapy. We are seeking talented, devoted and team-oriented employees. Aduro is an equal-opportunity employer and offers a competitive benefits package.
Please view the current opportunities below. To apply, please send a pdf of your resume to: firstname.lastname@example.org
Thank you for your interest in Aduro.
Summary and Scope of Position:
Support and facilitate the Regulatory Affairs (RA) activities within a highly regulated industry to ensure that Company products comply and meet regulatory requirements. Support Quality Assurance (QA) programs for compliance with applicable national and international regulations, standards, internal procedures and best practices. This is a split-function position which broadly covers both RA/QA support at Aduro.
Primary Responsibilities – Regulatory Affairs:
- Write, review and edit regulatory documentation (including routine correspondence, INDs, BLAs, NDAs, annual reports, amendments, orphan drug applications, supplements, etc)
- Support timely submission of regulatory documentation, including working with CROs to ensure this
- Support the Director, Regulatory Affairs in the preparation for publication and submission of a variety of regulatory documents
- Develop, coordinate, and document communications with regulatory agencies; may serve as secondary contact for regulatory agency interactions
- Perform other related duties as required
Primary Responsibilities – Quality Assurance:
- Manages internal document control system, including development of document templates and forms and GMP supporting documents; coordinates report generation from preclinical/research/product development studies
- Perform internal quality audits and facilitate corrective actions with the possibility of some external auditing support
- Prepare detailed Quality reports and supporting memos
- Review and/or approve manufacturing- and Quality Control-related documentation (internal and external), including batch record review, lot release and stability testing data
- Identify and perform other related duties as required (includes projects in the areas of compliance and quality systems)
- As necessary, provide QA guidance to other development and/or scientific staff
- Develop SOPs to cover RA/QA procedures
- Work with Director, Quality to accomplish internal goals
- Bachelor’s degree in a scientific discipline or equivalent with a minimum combination of 5 years relevant Regulatory Affairs and Quality Assurance experience in pharmaceutical, medical device and/or biotechnology companies
- Broad-based regulation/standards background and current understanding of RA/QA trends and guidances
- Strong communication (verbal, written, listening) and interpersonal skills; ability to communicate across multiple disciplines successfully and accurately (internally and externally, e.g., FDA, international regulatory authorities, contract research organizations (CROs) and contract manufacturing organizations (CMOs))
- Proficient in pharmaceutical technical writing such as SOPs, reports, quality documentation and regulatory submissions
- Experience reviewing technical documentation and reports
- Proficient in Microsoft Word, Visio, Excel and Adobe Acrobat
- Time management (timelines, schedules, task prioritization) and the ability to work independently
- Attention to detail and accuracy
- Ability to integrate the needs of QA/RA with organizational objectives
- Flexible; ability to adapt to changing priorities
- Able to understand scientific, medical and manufacturing disciplines
Summary & Scope of Position:
A lead project management position in a growing immunotherapy program focused on therapeutic cancer vaccines. Initial focus will be on direct support of project teams, interaction with corporate partners, and establishment of project management systems to ensure accountability and timeliness. Opportunity to develop a project management function through establishment of systems and new hires for the company as the need grows. Role in corporate planning and portfolio management.
- Manage project teams, together with technical project leader.
- Take responsibility for product development plans, budgeting, and timelines.
- Contribute to strategic decisions by team on important development choices; lay out alternatives, analyze implications of choices, represent fiscal perspective in decision making; develop solutions to issues as they arise.
- Play key role in developing annual operating plan including task prioritization, staffing and budgeting.
- Facilitate corporate Portfolio Review Committee together with head of business development.
- Communicate the status of projects and related issues on a routine basis to senior management.
- Establish and maintain relationships with corporate partners to ensure smooth communication and functioning between organizations.
- Identify and track critical path issues/activities; enlist key people to resolve these obstacles in order to expedite each project through all stages of development.
- Work with diverse groups, including clinical, research, manufacturing, quality and regulatory to ensure timelines are achieved.
- Implement project management tools and develop appropriate systems to meet company needs as vaccines area grows.
- Define, implement and support the team structure and operating guidelines.
- Bachelor of Sciences in a scientific discipline or Engineering degree; PhD and/or MBA a plus.
- A minimum of 5 years of project management experience in the pharmaceutical, biotechnology or medical device areas; relevant experience outside of project management will be considered a positive; experience in oncology, immunotherapy or biologics preferred.
- Experience collaborative partnerships and clinical trials through Phase 3.
- Working familiarity with pre-clinical and clinical development, regulatory and manufacturing related to therapeutics/biologics development.
- Must have proven skills in using and developing project management/project office tools.
- Ability to effectively and constructively communicate, coordinate, cooperate and interact with all levels, including senior management.
- Strong influence management capabilities in a cross-functional organizational setting.
- Demonstrated capacity to manage subordinates, and to hire, train, mentor and develop project managers as this function grows.
Summary & Scope of Position:
Lead and manage the development of microbiological immunotherapy products for Phase 1-3 clinical studies with the ultimate goal of achieving commercial/marketed status.
- Manage and oversee Contract Manufacturing Organization (CMO) activities associated with Process Development (PD), GMP manufacturing and release support of microbiological immunotherapy products
- Manage technical transfers of microbiological production processes from Ph1/2 level CMO to Ph3/commercial CMO
- Review batch records, interact with CMO for any discrepancies, and coordinate with Aduro Quality to release clinical API, drug substance and/or drug product
- Manage drug product distribution cold-chain
- Author and review CMC sections for INDs, MFs and BLAs
- Assist in potency assay development for characterization of microbiological therapies
- Establish scale-up of critical manufacturing processes identified through design analyses
- Prepare documentation for, and oversee product stability studies at CMO
- Establish annual goals for Microbial Immunotherapy PD to support clinical inventories and subsequent product licensure
- Provide validation leadership for manufacturing process at CMO
- Represent Microbial Immunotherapy PD in project team meetings
- Participate in and support development of cellular immunotherapies
- Bachelor’s degree, preferably in microbiology or bio-engineering; advanced degree a plus
- 6+ years pharmaceutical industry experience with microbial or cellular therapies
- CMO Management experience
- In-depth understanding of the GMP environment
- Knowledge of the regulatory requirements for US and ex-US
- Excellent project management skills with ability to develop/manage budgets and timelines and schedule and prioritize activities
- Strong communication (verbal and listening) skills with ability to communicate across multiple disciplines effectively (internally and externally, e.g. CMOs)
- Effective writing skills essential
- Strong leadership, management and mentoring skills; team-oriented
- Results-driven with attention to detail and accuracy
- Flexible, with ability to adapt to changing priorities
- Work effectively in a team environment
- Able to understand complex scientific, medical, and manufacturing disciplines
- Willingness to travel (domestic and international) up to 20%