Harmony Biosciences
Associate Director, Analytical Development
Harmony Biosciences, Plymouth Meeting, Pennsylvania, United States
Harmony Biosciences is recruiting for an
Associate Director, Analytical Development
in our Plymouth Meeting, PA location.
In this role you will support the operations of the Technical Operations organization for Harmony. These duties will include primarily supporting analytical development oversight of multiple drug substance and drug product contractors, enabling supplies for commercial or clinical use. This position will coordinate and execute analytical activities for clinical and development programs at Harmony to support uninterrupted supply of pharmaceutical drug products of the highest quality for our patients. Responsibilities include but are not limited to: Serve as analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product (oral solids/liquids and other dosage forms) development and manufacturing at contractor sites Lead and support analytical development activities at multiple contractor sites related to analytical method development, method improvements, product characterization and comparability assessments for Harmony's early and late-stage programs Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities: Serve as technical expert on drug substance and drug product aspects with particular emphasis in analytical chemistry and associated methodologies Provide oversight and serve as technical lead for the execution of method development, method improvement and method validation activities Manage laboratory deviations / investigations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony's Quality function Oversee and co-manage release testing and stability programs for drug substance and drug product with Quality Assurance Ensure COs meet Harmony business objectives while meeting quality and compliance standards Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility Review and maintain lifecycle product documentation and data files related to analytical activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, etc. Collaborate with other Harmony departments as required to achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients Work closely with teams to define analytical testing strategy Develop and maintain technical aspects of quality agreements Implement analytical improvement or analytical aspects of other product lifecycle programs Lead the execution of analytical technology transfers, method implementation, qualification/validation Prepare and review dossiers for regulatory filings Drive fiscal responsibility with the operational budget and cost savings initiatives Qualifications: Bachelor's Degree in analytical chemistry, pharmaceutical sciences, or a related field required; MS or PhD preferred. 8+ years of experience in analytical method development and validation within the pharmaceutical industry required Technical proficiency in analytical method development (dissolution, chromatographic and spectroscopy techniques), method robustness and qualification/validation requirements is required; experience with managing CMO's is a plus. Experienced with state-of-the-art technical and compliance guidance to drive qualitative and quantitative chemical analysis, and characterization of drug substances and drug products of the highest quality Knowledge and application of pharmaceutical analytical development principles, concepts, industry practices to assist during audits or vendor inspections, and offer solutions to troubleshoot technical problems Proven track record in developing and transferring analytical methods from R&D to commercial stage of product lifecycle Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles (ICH, USP and ISO standards), with particular emphasis on laboratory techniques and procedures Strong computer, organizational, and analytical skills required Physical demands and work environment: Travel (both domestic and international) is estimated to be 25% of the time for this position. While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (laboratory/manufacturing). Hearing protection will be required at times. Specific vision abilities required by this job include: Close vision. Manual dexterity required to use computers, tablets, and cell phone. Continuous sitting for prolonged periods. What can Harmony offer you? Medical, Vision and Dental benefits the first of the month following start date Generous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings Plan Paid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunities A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture
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Associate Director, Analytical Development
in our Plymouth Meeting, PA location.
In this role you will support the operations of the Technical Operations organization for Harmony. These duties will include primarily supporting analytical development oversight of multiple drug substance and drug product contractors, enabling supplies for commercial or clinical use. This position will coordinate and execute analytical activities for clinical and development programs at Harmony to support uninterrupted supply of pharmaceutical drug products of the highest quality for our patients. Responsibilities include but are not limited to: Serve as analytical Subject Matter Expert (SME) for clinical and development programs, including drug substance and drug product (oral solids/liquids and other dosage forms) development and manufacturing at contractor sites Lead and support analytical development activities at multiple contractor sites related to analytical method development, method improvements, product characterization and comparability assessments for Harmony's early and late-stage programs Direct technical oversight of multiple Contract Organizations (COs), with the following responsibilities: Serve as technical expert on drug substance and drug product aspects with particular emphasis in analytical chemistry and associated methodologies Provide oversight and serve as technical lead for the execution of method development, method improvement and method validation activities Manage laboratory deviations / investigations to successful closure in a timely manner as product SME in close and seamless collaboration with Harmony's Quality function Oversee and co-manage release testing and stability programs for drug substance and drug product with Quality Assurance Ensure COs meet Harmony business objectives while meeting quality and compliance standards Drive uncompromising quality as a fundamental and valued attribute of all output and patient safety as an overarching responsibility Review and maintain lifecycle product documentation and data files related to analytical activities for early and late-stage development programs, including but not limited to protocols, reports, SOPs, certificates, etc. Collaborate with other Harmony departments as required to achieve corporate goals and mission for uninterrupted clinical and commercial supply to patients Work closely with teams to define analytical testing strategy Develop and maintain technical aspects of quality agreements Implement analytical improvement or analytical aspects of other product lifecycle programs Lead the execution of analytical technology transfers, method implementation, qualification/validation Prepare and review dossiers for regulatory filings Drive fiscal responsibility with the operational budget and cost savings initiatives Qualifications: Bachelor's Degree in analytical chemistry, pharmaceutical sciences, or a related field required; MS or PhD preferred. 8+ years of experience in analytical method development and validation within the pharmaceutical industry required Technical proficiency in analytical method development (dissolution, chromatographic and spectroscopy techniques), method robustness and qualification/validation requirements is required; experience with managing CMO's is a plus. Experienced with state-of-the-art technical and compliance guidance to drive qualitative and quantitative chemical analysis, and characterization of drug substances and drug products of the highest quality Knowledge and application of pharmaceutical analytical development principles, concepts, industry practices to assist during audits or vendor inspections, and offer solutions to troubleshoot technical problems Proven track record in developing and transferring analytical methods from R&D to commercial stage of product lifecycle Knowledge of regulatory environment (FDA/ICH regulations) and experience with organizing and writing regulatory submissions Knowledge and demonstrated mastery of current Good Manufacturing Practices (cGMPs) and associated quality guidance and principles (ICH, USP and ISO standards), with particular emphasis on laboratory techniques and procedures Strong computer, organizational, and analytical skills required Physical demands and work environment: Travel (both domestic and international) is estimated to be 25% of the time for this position. While performing the duties of this job, the noise level in the work environment can vary from relatively quiet (office) to moderate (laboratory/manufacturing). Hearing protection will be required at times. Specific vision abilities required by this job include: Close vision. Manual dexterity required to use computers, tablets, and cell phone. Continuous sitting for prolonged periods. What can Harmony offer you? Medical, Vision and Dental benefits the first of the month following start date Generous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings Plan Paid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunities A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture
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