Manager, Biologics Technical Development

Location
South San Francisco, CA, United States
Posted
Nov 08, 2020
Ref
R0002141
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

The Manager in Biologics Technical Development is responsible for formulation and analytical development of biologic molecules. The candidate will be responsible for preparing and reviewing development protocols, executing laboratory experiments, generating and processing raw data and preparation/review of technical reports. The candidate will be responsible for share and communicating technical information cross-functionally via reports and presentations. This position will work closely with the scientists in Formulation Development, Analytical Development, Quality Assurance and Quality Control groups to provide technical insights and support of new product development to meet Corporate Goals and Objectives. Experience in formulation or analytical development of biologics, method transfers and troubleshooting analytical and technical issues on development and commercial products is strongly preferred. Hands on experience wet-lab experience with basic laboratory equipment and methods for biologics is required.

Responsibilities:
  • Provide technical oversight of formulation and analytical development activities of biologic drug products, such as compatibility studies, formulation screening, supportive stability, analytical testing, method development, and method optimization
  • Set up and perform experiments in the laboratory in support of formulation, analytical method development, manufacturing process development, and troubleshooting.
  • Hands on experience handling and trouble-shooting laboratory instruments, including HPLC (SEC, CIEX, RP assays), UV-Vis, capillary electrophoresis (CE-SDS, cIEF assays), subvisible particle analysis (MFI, HIAC), etc.
  • Identifies analytical science capabilities and technology tools needed to enable product and process development activities
  • Applies scientifically driven thinking to the development of scientifically sound experimental design and data interpretation
  • Coordinates with other internal departments to review/approve protocols for development studies, tech transfer/ qualification of analytical methods, data summaries and technical reports
  • Manage and analyze datasets to support setting of specification limits and trending of manufacturing and analytical data. Use current statistical approaches for data analysis.
  • Prepares and delivers technical reports, documents, batch analyses, analytical data etc. for regulatory submissions.


Qualifications and Skills Required:
  • B.S. in chemistry, biochemistry or other scientific discipline
  • 5+ years of wet lab experience in a pharmaceutical/analytical development
  • Technical understanding and experience with protein or biologic molecules
  • Hands on experience in handling laboratory instruments, including HPLC (SEC, CIEX, RP assays), UV-Vis, capillary electrophoresis (CE-SDS, cIEF assays), subvisible particle analysis (MFI, HIAC), etc.
  • Experience trouble-shooting analytical methods and maintaining laboratory equipment
  • Detail-oriented, with good organizational and project management skills. Ability to effectively prioritize and deliver on tight timelines.
  • Good oral and written communications skills; proficient with MS Word, PowerPoint, Excel
  • Ability to establish and maintain effective working relationships.
  • Ability to recognize the potential of new technologies to meet analytical testing requirements.
  • Bench work expected for this position is about 70%


Preferred Knowledge, Skills, and Abilities
  • Experience with DOE study design and data analysis is preferred
  • Experience with statistical data analysis and stability trending is preferred
  • Working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (ICH and FDA) as they relate to biologics is preferred


Horizon Core Values & Competencies:

Growth
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent


Accountability
  • Drives Results
  • Ensures Accountability
  • Decision Quality


Transparency
  • Courage
  • Collaboration
  • Instills Trust


Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.