Support the formulation and characterization efforts for biotherapeutic drug product discovery and development across different therapeutic areas, performing protein analytical techniques and facilitating tech transfer activities.
Compensation
$103,000.00-131,000.00 Annual
Responsibilities
Perform protein analytical techniques to inform formulation and process optimization
Assess biotherapeutic stability as a function of formulation and process
Facilitate tech transfer activities
Document experiments using electronic lab notebook
Lead commercial drug product programs as DPTL and lead a scientific team that supports advancing the commercial drug product programs in our portfolio.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 157,737.05USD -213,408.95 USD
Responsibilities
Lead a team of scientists focused on late-stage drug product process development and tech transfer
Coach staff with emphasis on people-centered leadership
Provide support to clinical and commercial fill/finish manufacturing operations
Drive continuous improvement in the drug product development process
Participate and lead global cross-functional teams
Imagine being at the forefront of delivering life-changing sterile medicines to patients around the world. As Sr. Engineer, Manufacturing Science and Technology – Aseptic Drug Product, you will play a critical role in advancing aseptic manufacturing operations by providing technical leadership, driving process performance, and supporting the successful introduction of new products and technologies.
Compensation
The salary for this position is expected to range between $114,100 and $211,900 annually
Responsibilities
Lead CPV activities by analyzing process data, identifying trends, and driving process performance improvements.
Serve as the MS&T technical lead for manufacturing investigations, root cause analysis, and issue resolution.
Partner with Manufacturing to support production schedules, commercial supply, and compliance with GMP requirements.
Monitor and trend CQAs and CPPs to ensure consistent product quality and process control.
Identify, evaluate, and implement process improvements that enhance reliability, efficiency, and performance.
Requirements
Bachelor's degree in Biochemistry, Chemical Engineering, Bioengineering, or a related technical field with 6+ years of biopharmaceutical manufacturing experience; Master's degree with 4+ years of experience; or Doctorate degree with 2+ years of experience.
The Associate Director of Formulation Development will provide scientific and strategic leadership for early- and late-stage formulation development activities supporting phase-appropriate formulations of biologic drug products, with a focus on monoclonal antibodies, bispecific formats, and co-formulations.
Locations (2)
Menlo Park, California, United States
Waltham, Massachusetts, United States
Compensation
The anticipated salary range for candidates, who will work in Waltham, MA or Remotely is $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
Responsibilities
Lead phase-appropriate formulation development workflows for biologics, including selection, optimization, and robustness studies, with a focus on high concentration product development.
Experience with co-formulation products.
Experience with PFS and Autoinjector selection and testing.
Partner with drug product and clinical teams to ensure appropriate container closure selections are made that align with QTPP and clinical needs.
Project Manager III, Tech Transfers, External Manufacturing 1
Lead the TSMS organization for Elanco External Manufacturing API China, managing contract manufacturers and key suppliers to drive technical innovation, process productivity, and successful technology transfers.
Responsibilities
Lead and develop a high-performance TSMS team
Govern the full technical lifecycle of API manufacturing
Drive the process productivity agenda
Serve as the primary technical escalation point
Cultivate strong technical networks with Global TSMS and cross-functional partners
Requirements
Ph.D. degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or related Chemical/Pharmaceutical Sciences
Nice to have: overseas education or professional experience within global Pharma or CDMOs
Nice to have: direct technical management experience overseeing external manufacturing partners
Nice to have: familiarity with Design of Experiments (DoE)
Associate Director, Formulation Development, Tech Ops (Biologics)Oruka Therapeutics · Menlo Park, US+1 more
Project Manager III, Tech Transfers, External Manufacturing 1Teva Pharmaceuticals · India
Principal Scientist, Upstream Process DevelopmentMerck · Rahway, US