Scientist-III

Responsibilities:
Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
Support scale-up and technology transfer activities to internal and external manufacturing sites.
Keep abreast of the latest advances in biologics formulation and process technologies.
Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable.

Qualifications:
Proven ability to solve critical scientific problems.
Hands-on experience with biologics formulation development .
Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
Solid understanding of biologics degradation mechanisms and stabilization strategies.
Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
Understanding of relevant cGMP and regulatory guidance.
Experience with sterile manufacturing unit operations (freez-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
Experience with quality risk management and drug product control strategies.

Skills:
Hands-on experience with biologics formulation development .
Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
Proven ability to solve critical scientific problems.
Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.

Experience Level:
Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.

EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.