PharmaLex
Process Development Scientist role at PharmaLex.
Shift: Administrative.
Location: Juncos, PR.
Education: Doctorate OR Masters + 2 years scientific experience OR Bachelors + 4 years scientific experience.
Responsibilities
Conceives and designs, executes or evaluates experimental strategies. Provides input to new processes to generate robust and reliable data, ensuring studies are conducted in compliance with protocols and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, assessing impact of data on the project. Keeps current in scientific expertise and relevant areas. Monitors field of expertise, including literature and technology development, communicating relevant observations. May introduce advanced scientific methods, developing and implementing new protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside the department or company. Advises or assists others in experimental design and interpretation of data, independently authoring scientific reports, summary documents, regulatory documents, disclosures and patents, participating in external scientific community. May assume lead role in departmental support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills, following timelines for completing project team work. Preferred Qualifications
Provide advanced technical support to automatic packaging equipment and processes. Strong knowledge of vision system technologies. Inspection and packaging concepts knowledge. Strong knowledge with local process flow, layouts and general packaging SOPs to define details of serialization solution. Support troubleshooting, investigations, root cause analysis related to packaging area and inspection process. Identify and implement initiatives to reduce manufacturing operational costs while maintaining product quality. Development and execution of process characterization. Establish testing strategies. Design and development of characterization protocols. Technical reports development. Validations and technical reports to support SAT executions, document generation and challenge validations strategies. Risk assessments and QRAES knowledge to support risk assessment activities. Project execution coordination (material requests, trainings, production windows, work order generation). Technical documentation abilities, oral and written. Documentation software proficiency (MS Word, Excel, PowerPoint, PDF, Visio, MS Project). Project management basics (timeline follow up, schedule reviews, predecessor). People skills for OEMs and interdisciplinary share. Self‑driven and schedule oriented. Skills
Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others. Well organized, multi‑task project experience, and able to communicate and work well with other departments. Demonstrated verbal and written communication, technical writing, negotiation and conflict resolution skills. Analytical problem solving and project management. Flexibility and change management. Computer literacy (Windows: Word, Excel, PowerPoint). Application of scientific theory. Creative design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMPs. Fully bilingual (English/Spanish). Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.
#J-18808-Ljbffr
Conceives and designs, executes or evaluates experimental strategies. Provides input to new processes to generate robust and reliable data, ensuring studies are conducted in compliance with protocols and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, assessing impact of data on the project. Keeps current in scientific expertise and relevant areas. Monitors field of expertise, including literature and technology development, communicating relevant observations. May introduce advanced scientific methods, developing and implementing new protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside the department or company. Advises or assists others in experimental design and interpretation of data, independently authoring scientific reports, summary documents, regulatory documents, disclosures and patents, participating in external scientific community. May assume lead role in departmental support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills, following timelines for completing project team work. Preferred Qualifications
Provide advanced technical support to automatic packaging equipment and processes. Strong knowledge of vision system technologies. Inspection and packaging concepts knowledge. Strong knowledge with local process flow, layouts and general packaging SOPs to define details of serialization solution. Support troubleshooting, investigations, root cause analysis related to packaging area and inspection process. Identify and implement initiatives to reduce manufacturing operational costs while maintaining product quality. Development and execution of process characterization. Establish testing strategies. Design and development of characterization protocols. Technical reports development. Validations and technical reports to support SAT executions, document generation and challenge validations strategies. Risk assessments and QRAES knowledge to support risk assessment activities. Project execution coordination (material requests, trainings, production windows, work order generation). Technical documentation abilities, oral and written. Documentation software proficiency (MS Word, Excel, PowerPoint, PDF, Visio, MS Project). Project management basics (timeline follow up, schedule reviews, predecessor). People skills for OEMs and interdisciplinary share. Self‑driven and schedule oriented. Skills
Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others. Well organized, multi‑task project experience, and able to communicate and work well with other departments. Demonstrated verbal and written communication, technical writing, negotiation and conflict resolution skills. Analytical problem solving and project management. Flexibility and change management. Computer literacy (Windows: Word, Excel, PowerPoint). Application of scientific theory. Creative design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMPs. Fully bilingual (English/Spanish). Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.
#J-18808-Ljbffr