Director, CMC Operations

Xilio Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 03/31/2021
  • Website: www.xiliotx.com
  • Company Address: 828 Winter Street, Waltham, MA, 02451

About Xilio Therapeutics

Xilio Therapeutics is a biopharmaceutical company focused on developing highly-potent, targeted immuno-oncology therapeutics.

Job Description

Xilio Therapeutics is a development-stage biotechnology company advancing next-generation cancer immunotherapies designed to improve patient outcomes by unleashing the power of the immune system selectively at the site of the tumor. The company’s tumor-selective immunotherapies are based on its proprietary technology, which maximizes the potency of proven immuno-oncology therapies and restricts their activity to the tumor to minimize peripheral side effects. The broad applicability of these therapies across cancer types means that all patients could benefit from these potentially curative medicines.

Xilio was founded in 2016 and closed a $100.5M Series B financing from blue chip venture investors in February 2020. Xilio is headquartered in Waltham, MA.

SUMMARY:

Xilio is searching for a Director CMC Operations to take on broad responsibility for coordinating CMC development activities and compliance processes/procedures, maintaining operational visibility for these activities, and also long-range CMC planning. This is a key organizational and leadership role within a focused team accountable for overseeing all aspects of CMC development, from cell-line development through to GMP/clinical manufacture at Xilio partner\ CDMOs. This role will also require the ability to communicate across international cultures and across Xilio internal department interfaces. The role provides alliance and project management expertise and the ability to balance CMC priorities and outcomes to meet the needs of customers in Clinical Development, Nonclinical and Translational Development, Research, QA and Program Leadership.

The position will be based in Waltham, Massachusetts, and reports to the Vice President, CMC.

RESPONSIBILITIES:

  • Planning, scheduling, maintenance of dashboards, QPIs/metrics, and co-ordination of reporting on all CMC activities
  • Overall management and co-ordination of GMP procedures including product quality complaints, product recovery, deviations/OOS, root cause analysis & quality investigations and change control
  • Take the lead in CMC risk identification, mitigation, and management
  • Coordinate, develop and manage CMC quality system documents including: Quality Agreements, Work Instructions, SOPs, Specifications and Policies
  • CMC SME for GMDP Quality and Quality Audits
  • Co-ordinate CMC activities with internal stakeholders to ensure all required materials (product and placebo) are available for nonclinical and clinical studies. This includes, quantity, formulation, container size, diluents and supporting data (e.g., solubility, developability & stability data, specification, and QC data)
  • CMC oversight and verification of unlabelled DP vial shipments according to GDP
  • Oversight of GMP DS/DP manufacturing at CDMOs
  • Co-ordinate assembly and technical review of batch manufacturing documentation in support of final batch disposition
  • Maintain Xilio archive of CMC development and manufacturing documentation
  • Working with the CMC team members, ensure budget spends are tracked

REQUIREMENTS:

  • Bachelor’s degree required.
  • 5+ years of relevant industry experience, including drug product development experience.
  • Experience in a CMC development environment required.
  • Proven leadership and cross-functional management of CMC projects.
  • Ability to translate complex concepts into actionable and measurable tasks.
  • Excellent people management skills with the ability to develop effective relationships, motivate others and influence in a cross-functional environment.
  • High initiative, strong drive and follow-through.
  • Requires flexible work schedule to accommodate program priorities and international activities.
  • Working knowledge of regulatory CMC and related guidance documents.
  • Broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies.
  • Must have outstanding communication and collaboration skills within cross-functional team and external organizations.
  • Must have the ability to successfully function in a rapidly changing environment.
  • Strong interpersonal communication skills, ability to negotiate and influence partners towards an appropriate path forward is required.
  • Able to prioritize duties and manage multiple projects with limited supervision.

Xilio offers the opportunity to work in an innovation driven, exciting biotechnology company doing ground-breaking work in the field of immuno-oncology. We offer a competitive compensation package including a base salary, annual bonus potential, stock options, 401k, healthcare benefits and paid time-off.

POSITION: Full-Time, Exempt

EEOC Statement: Xilio Therapeutics believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Xilio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.