Sr. ScientistEngineer, Process Development
Job Location:
Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
5 hours ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patientcentric solutions developing and commercializing innovative inhaled therapeutics and drugdevice technologies aimed at addressing serious unmet needs across endocrine cardiorenal and orphan lung diseases. The company applies deep expertise in formulation science and inhalationdevice engineering to reduce the treatment burden for conditions such as diabetes congestive heart failure pulmonary fibrosis and pulmonary hypertension.
MannKinds core technologies including ultrafine drypowder formulations and advanced inhalation platforms enable rapid convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms MannKind aims to bring forward differentiated patientcentric therapies that expand treatment options to improve outcomes across chronic and rare diseases.
At MannKind our employees are our greatest asset. We foster a close-knit collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds perspectives and working styles as we work together to improve health outcomes and change lives.
Position Summary:
Provide advanced scientific and technical leadership in the development optimization scale-up and lifecycle management of pharmaceutical manufacturing processes across the product lifecycle. Operate as a senior individual contributor within the process development department applying a high degree of independence technical judgment and subjectmatter expertise. Support clinical and commercial manufacturing by ensuring processes are scalable robust and compliant while contributing to crossfunctional technical decisionmaking and continuous improvement across MannKinds product portfolio.
Essential duties and key job responsibilities and essential functions:
- Lead the design development and optimization of pharmaceutical manufacturing processes from late-stage development through commercialization.
- Apply sound scientific principles experimental design anddatadrivenmethodologies toestablishprocess understanding and improve process robustness and capability. Independently plan execute analyze and document complex experimental studies in support of process development and process characterization.
- Serve as a subject matter expert for specific unit operations process technologies or platform processesprovidingtechnical guidance across functions.
- Support processscaleup technology transfer and process validation activities by generating technical documentation and providinghandsonor consultative support.
- Collaboratecrossfunctionallywith manufacturing engineering quality analytical development regulatory and external partners to ensure successful process implementation.
- Manage equipmentmaintenance includingcalibrations/qualifications.
- Support investigations related to process deviations manufacturing issues and continuous improvement initiatives.
- Author and review development reports protocols technical summaries and regulatory documentation in compliance with cGMP and regulatory expectations.
- Contribute to process lifecycle management activities including continuous improvement change management and technical risk assessments.
- Provide technical mentorship and informal coaching to junior scientists and associates to elevate team technical capability.
- Responsible forobservingall Company Health Safety and Environmental guidelines.
- Duties and responsibilities are not limited to the work listed above and may include otherassignmentsas necessary.
Minimum qualification to perform the job; specific skills; education; knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- BS/BA with 6-8 years MS with 46 years or PhD or of relevant experience in Chemistry Chemicalengineeringor a related field with experience in pharmaceutical process development and/or manufacturing support.
- Experience inthe development and scale-up of drugmanufacturing processes.
- Experiencepreferred in the manufacturepackagingand kitting of clinical phase drug products.
- Experience with orally inhaled dosage formsis strongly preferred.
- Experience withthe following unit operationspreferred:spray dryingwet nano-millingtangential flow filtrationmicro fluidization.
- Experience managing second-party resources includingclinicalpackaging vendors and contract development and manufacturingorganizations.
Required Experience:
Senior IC
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
