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This drug product device engineer will be a key contributor in drug device development developing device functionality tests design control developing device assembly process tech transfer device related qualifications and continuous improvement in Dr. Reddys Biologics
Qualification:
Drug device development such as prefilled syringe with needle safety device manual injectors autoinjector/pen and wearable devices.
SME from developing biologics drug devices
Accountable in developing device functionality test methods and transfer of methods to QC for release testing
Expertise in primary container (Vial stopper PFS) selection for biologic drug product through stability studies
Qualifications :
Educational qualification: B.Tech. or B.Pharm. or M.Tech. or M.Pharm. or Ph.D
Minimum work experience:
12 years of experience for BS and 6 years of experience for MS or PhD in device development test method development device assembly filling and packaging processes for biologics drug products
Strong knowledge on standards and regulations: Quality System Regulation 21CFR820 ISO 13485 and ISO 11608.
Excellent technical writing skills
Skills & attributes:
Technical Skills
Basic knowledge of pharmaceutical industry and regulatory market.
Expertise in developing Devices for Drug product ideas and concepts.
Strong market research capabilities to identify unmet needs assess product fit and determine positioning strategies.
Behavioural skills
Excellent communication and interpersonal skills to engage with internal and external stakeholders.
Strong analytical and critical thinking abilities to evaluate opportunities and make informed decisions.
Collaboration and teamwork skills to establish relationships with potential partners and align with product stakeholders.
Strategic mind set to align portfolio management with business objectives and priorities.
Leadership and influence skills to drive portfolio decisions and manage risk effectively.
Additional Information :
NA
Remote Work :
No
Employment Type :
Fulltime
Full-time