Lead Formulation & DP

The successful candidate will be responsible for Biologics formulation development activities

1) Lead a team of formulation development scientists

2) Responsible for developing novel formulations for pipeline biosimilar products (mAbs Fusion proteins Bispecific and ADCs)

3) Support the transfer of formulation and drug product process to scale-up and tech transfer groups

4) Manage the formulation and DP Process development activities using in-depth scientific understanding on protein stability and degradation pathways.

5) Responsible for developing platform based high throughput analytical methods for formulation development

6) Support regulatory filing activities

Qualifications :

Qualifications:

Demonstrated experience with the formulation development of biologics and drug product process from bench to pilot scale. Expertise in analytical and characterization methods (HPLC UPLC CE-SDS MFI DLS and LC-MS) and unit operations required for drug product manufacturing. Experience in DP process characterization studies using design of experiments (DoE). Expertise in Drug device development (Safety device and Autoinjector) for regulated market. Good verbal and written communication skills; good problem solving abilities; and good organizational skills.

Education:

PhD in Pharmaceutics Biochemistry Biotechnology Chemical Engineering with 10 years experience in biologics formulation development and drug product development.

Master degree in Pharmaceutics Biochemistry Biotechnology Chemical Engineering with 18 years experience in biologics formulation development and drug product development.

Additional Information :

Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1