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Director/Senior Director, Formulations

Employer
Coherus BioSciences
Location
Camarillo, California
Start date
Dec 5, 2021

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

Title:                              Director/Senior Director, Formulations Reports To:                   Executive Vice President, Analytical Sciences & Formulations
Location:                       Camarillo, CA
Classification:               Exempt

Overview:

Provide strategic and technical leadership for the development of novel formulations, and activities required for IND applications, product licensure and GMP compliance.

The successful candidate will design key experiments, direct, prepare and review protocols, data and study reports, oversee activities at contract labs, prepare summaries and presentations and communicate results to technical, development and legal management. This position will work closely with leaders and scientists in Analytical Development, Process Development, Manufacturing and Quality groups to provide technical insights and support of new product development to meet Corporate Goals and Objectives. The Director/Senior Director of Formulation Development will also be a scientific resource during the manufacturing of new products to support process development, scale-up, analysis of new findings and troubleshooting of issues, as well as a resource for the Business Development Team during review of potential new product candidates.

Duties and Responsibilities:

  • Provides strategic leadership, technical expertise, and specialized knowledge for biopharmaceutical formulation development
  • Identifies analytical science capabilities and technology tools needed to enable formulation development, QC testing, deviation investigation and new drug candidate formulation development
  • Applies scientific thinking to the design of sound, well understood, and robust experimental plan to support new formulations and manufacturing troubleshooting
  • Reviews and interprets data and reports associated with stability testing and other characterization testing of new drug products and formulations
  • Provides technical input and oversight related to formulations used and/or prepared by CMOs and contracting testing laboratories, including the review and approval of test records, forms, methods, protocols and reports for nonclinical and clinical studies
  • Prepares technical reports, formulation development reports and related documents to support regulatory submissions
  • Serves as SME for areas of responsibility during regulatory inspections
  • Provides support and contributes to Development, Pharmaceutical Sciences and cross-function activities as needed

Qualifications:

  • Bachelors or PhD in chemistry, chemical engineering, pharmaceutical development or other relevant scientific discipline
  • With PhD - 10+ years in the industrial biopharmaceutical formulation development field
  • With Bachelors - 15+ years in the industrial biopharmaceutical formulation development field
  • Experience in pharmaceutical development of peptides and proteins is required

Experience:

  • Experience with managing internal and contract labs for pre-formulation and formulation development and testing
  • Hands-on experience with formulation development
  • Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products
  • Ability to establish and maintain effective working relationships
  • Ability to effectively prioritize and deliver on tight timelines
  • Outstanding problem solving abilities
  • Ability to recognize the potential of new technologies to meet analytical or QC testing requirements.
  • Detail-oriented, with good organizational and project management skills
  • Good oral and written communications skills
  • Proficient with MS Word, PowerPoint, Excel

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 

Company

Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.

Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

•    Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our

     employees, their eligible spouses, dependents, and domestic partners.
•    Health Savings and Flexible Spending Accounts
•    Group Life, Disability, and Group Accident Insurance
•    401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
•    Paid Time Off (PTO) 
•    Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
 

Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out: https://www.coherus.com/about-coherus/

Company info
Website
Phone
800-794-5434
Location
333 Twin Dolphin Dr, #600
 Redwood City
CA
94065
United States
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