SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Director, Formulations & Process Development to join the growing Chemistry, Manufacturing and Controls (CMC) team at our Research & Development office in Corvallis, Oregon. The Director is responsible for developing and optimizing formulations, process scale up and validation, and overseeing Contract Manufacturing Organizations (CMOs)/Contract Research Organizations (CROs) to streamline work flow and improve commercial production efficiency. As a leader of these functional areas, this position to the Vice President, Drug Development & Technical Operations and plays critical roles in cross functional teams to implement strategies for meeting overall company goals and objectives. This is a full time (40 hours/week) position eligible for SIGA’s full benefits package including company paid medical, dental, and visions benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option for a hybrid work arrangement and may require domestic travel up to 20% of the time.

Responsibilities for this position include:

· Develop and optimize oral solid, suspension and injectable formulations (e.g. tablet, capsules, ASD, HME) that are stable and suitable for Phase 3 or pivotal clinical studies and regulatory submissions.

· Design and monitor studies to screen and optimize prototype formulations

· Summarize experimental data and provide recommendations for final formulation of commercial product(s)

· Ensure product development files are complete and accurate (e.g. development report)

· Partner with Regulatory Affairs and provide relevant technical documents for timely submission of regulatory filings

· Manage and coordinate projects with Analytical, Quality and Regulatory to provide drug product supplies for clinical studies and supply chain distributions

· Transfer formulation and manufacturing knowledge to existing or new CMO

· Develop scalable manufacturing processes of solids and injectables for clinical supplies and supply chain

· Identify, purchase and qualify raw materials, packaging components, equipment for scale up and validation as necessary

· In partnership with Quality & Regulatory teams, develop, review, approve and oversee the execution of manufacturing and packaging documents for scale up and validation activities

· Prepare/review specifications with Analytical for drug substance, drug products and packaging components

· Perform other related duties as assigned

Minimum Qualifications include:

An advanced Degree (Ph.D. or equivalent) in a relevant field (i.e. Chemistry, Pharmaceutical Science, Chemical Engineering) with a minimum of 10 years experience in Pharmaceutical Development required

Experience working with novel compounds in the pharmaceutical industry and write up of regulatory CMC validation documents is strongly preferred

Preference will be given to candidates with recent experience in technical management with track record of successful NDA filing

The successful candidate will possess the following knowledge and abilities:

· Must be detail oriented and comfortable in a fast-paced, rapidly changing work environment requiring the ability to prioritize and multi-task.

· Able to work independently as well as in groups

· Must have strong, professional interpersonal skills including ability to communicate effectively with internal/external individuals and groups

· Must have a thorough understanding of good laboratory practices and their application.

· Familiarity with FDA guidance in the areas of cGMP, cGLP, ICH and global regulations

· Demonstrated ability for critical thinking and innovation

· Demonstrated ability to develop solid and injectable formulations for commercial distribution

About SIGA:

SIGA Technologies, Inc. is a public, commercial-stage pharmaceutical company focused on providing solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases. The company is headquartered in New York City, with research and development facilities in Corvallis, Oregon. In July 2018, the U.S. Food and Drug Administration (FDA) approved SIGA’s first product, oral TPOXX® (tecovirimat), for the treatment of smallpox. Oral TPOXX is a novel small-molecule drug that has been delivered to the U.S. Strategic National Stockpile (SNS) under the Project BioShield Act of 2004 (Project BioShield).

SIGA offers a challenging, growth-oriented environment with competitive compensation and a full benefits program.

SIGA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, age, national origin, predisposing genetic characteristics, unemployment status or veteran’s status and will not be discriminated against on the basis of disability.

Job Type: Full-time

Pay: From $145,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Corvallis, OR 97333: Reliably commute or planning to relocate before starting work (Required)

Education:

• Master's (Required)

Experience:

• CRO Management: 2 years (Preferred)
• CMO Management: 4 years (Required)
• pharmaceutical development: 8 years (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: In person

Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.