Senior Technical Officer - CMC
Job Description
Title: Senior Technical Officer - CMC
Company Name: U.S. Pharmacopeial Convention
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ Masters' degree in Pharmacy (M. Pharm), pharmaceutical science, chemistry, engineering or science related field of study required
Experience Requirements:
∎ At least 8 year(s)
Job Context:
∎ The Senior Technical Officer - Chemistry, Manufacturing and Controls (CMC) will have expert skills in pharmaceutical manufacturing and authoring the CMC sections of regulatory submissions. They must possess a deep understanding of the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will engage with and leads all technical support provided to pharmaceutical manufacturers in Bangladesh. As the lead for PQM+ pharmaceutical manufacturing activities in Bangladesh, the Senior Technical Officer provides technical oversight related to the program`s objective of increasing the supply of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, GMP, Dossier development and submission). Additionally, S/he acts is a recognized leader, interfacing with DGDA and stakeholders involved in supplying and manufacturing essential medicines.
∎ Position Type: Full-time/Regular
∎ Job Category: Global Public Health
Job Responsibilities:
∎ Provides technical oversight of activities to support local manufacturers in Bangladesh
∎ Leads in the delivery of trainings at regional and country level
∎ Provide oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
∎ Work closely with country teams to support development and deployment of strategies in pharmaceutical sector development
∎ Keep abreast of the latest analytical technology in industry and regulation requirements
∎ Technical POC at regional and country level such as Bangladesh Association of Pharmaceutical Industries (BAPI)
∎ Manages and mentors junior technical staff
∎ Recognized leader in the Bangladesh pharmaceutical sector actively advancing and deploying new technologies and trends in pharmaceutical manufacturing
∎ Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
∎ Supervisory Responsibilities:
∎ Reports will scale with program growth and will include relevant technical staff
Additional Requirements:
∎ Extensive [8 + years] experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals
∎ Substantive [3+ years] people management experience and skills
∎ Direct experience implementing USAID-funded programs
∎ Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices
∎ Strong written (especially technical writing) and oral communication skills
∎ Willingness to travel at least 25% of the time.
∎ Preferred Qualifications:
∎ Direct experience with and understanding of WHO pre-qualification process
∎ Experience at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
∎ Preferred Qualifications: Competency/Leadership Assessment
∎ Expertise:
∎ USP Acumen: Can explain USP's mission, organization and strategy in the context of the role, as well as policies, practices, and trends impacting USP and its stakeholders.
∎ Collaboration:
∎ Interpersonal Savvy: The ability to apply varying social skills across diverse situations to increase impact with people of different backgrounds and styles.
∎ Relationship Building: Regularly invests time in initiating and sustaining relationships with colleagues and external stakeholders to drive results
∎ Influencing Others: Able to communicate a unique individual perspective in a way that impacts others' thinking.
∎ Initiative:
∎ Innovation: Motivated to incorporate new ideas and thinking to everyday problems.
∎ Results Orientation: Consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy
∎ Growth:
∎ Developing Others: Places value in helping colleagues to growth by sharing targeted, actionable feedback and new insights on a regular basis.
∎ Leadership Competencies:
∎ Possess/Establishes Respect & Peer Credibility
∎ Matrixed/Collaborative & Demonstrates Global Approach
Application Deadline: April 25, 2020
Company Information:
∎ U.S. Pharmacopeial Convention
∎ Business : The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization founded in 1820. It sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP?s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Category: Medical/Pharma
Source: bdjobs.com
Deadline Expired on 25th Apr 2020
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