MannKind
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Job Summary
We are seeking a highly motivated and experienced scientist to join the Pharmaceutical Process Technology team. This role is to develop scientifically sound and robust pharmaceutical manufacturing process for pipeline assets from early to commercial phase thorough understanding of material characteristics, process chemistry, and working mechanism of pharmaceutical equipment.
Essential duties and key job responsibilities and essential functions
- Design and process development experiments to support the scale-up, and optimization of pulmonary delivered drug products.
- Establish process development database, perform data analysis and prepare technical reports documenting process performance and validating outcomes.
- Collaborate with cross-functional teams, including formulation development, analytical development, and quality assurance, to implement scalable and compliant processes.
- Provide support in maintaining inventory and coordinating the procurement or replacement of equipment and tools as directed.
- Provide hands-on support during scale-up and tech transfer activities for clinical and commercial manufacturing.
- Stay updated on process technologies, regulatory requirements, and industry trends to contribute to process innovation and compliance.
- Maintain well-organized records of experiments, protocols, and reports for internal use and regulatory submissions.
- Act as subject matter expert, independently identify and address process challenges, implementing improvements to enhance efficiency, quality, and scalability.
- Support formulation scale-up activities, ensuring successful transfer of processes from laboratory to manufacturing scale.
- Draft and execute engineering and validation protocols with minimal supervision.
- Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as 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.
- Bachelor's degree in Chemistry, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with 4-6 years of relevant industry experience, or a Master's degree with 2-4 years of experience, or a PhD (0-2 years of experience) in process or formulation development.
- Basic knowledge of cGMP standards and regulatory requirements for pharmaceutical manufacturing.
- Proficiency in data analysis and familiarity with technical tools/software (e.g., Excel, JMP, Minitab).
- Detail-oriented with strong organizational skills and the ability to contribute in a multidisciplinary team environment.
- Strong written and verbal communication skills, with the ability to document findings and collaborate effectively.
- Ability to write and execute protocols and assist in drafting detailed technical reports.
- Familiarity with formulation scale-up, process optimization, and tech transfer.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
|
Mannkind Corporation
Feb 22, 2025