Process Development Scientist

Weil Group•Juncos, PR

14h•Onsite

About The Position

Looking for a Process Development Scientist to join the Drug Product Process Development Compliance and Lab Operations Group based in Client’s East Area facility. The group provides scientific expertise and technical support to Client’s Drug Product commercial facility while supporting existing new product introductions, complaints, and deviations investigations. The Process Development Scientist must perform required tasks but not limited to: Monitors field of expertise, including literature and technology development, and communicates relevant observations. Understands and interprets primary components specifications and methods. Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications. Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis. Introducing advanced scientific methods. Develop and implement new and novel protocols to address specific issues. Represent the department on project teams under supervision. Initiate productive collaborations within and outside of the Process Development Department and Client Network. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participate with the external scientific community. Assume lead role in department-wide support efforts such as safety, OE and other committees. Develops and follows timelines for completing project teamwork. This position will be reporting to an administrative work schedule with flexibility to support the non-standard shift organization, as per business needs. The role is crucial for Client’s success and will be a key contributor to the Process Development-Drug Product organization. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Conduct research into the structures and properties of materials, such as metals, polymers, and ceramics to obtain information that could be used to develop new products or enhance existing ones. Determine ways to strengthen or combine materials or develop new materials with new or specific properties for use in a variety of products and applications. Develop testing methods to evaluate the effects of various conditions on containers materials Plan laboratory experiments to confirm feasibility of processes and techniques used in the production of materials having special characteristics. Perform experiments, records, organize data and analyze results under minimal supervision. Generates robust and reliable data in compliance with the respective protocols, methods or SOPs. Identify container components defects and provide solutions related to possible technical problems of moderate scope and complexity. Perform Container Defects, Primary Packaging and Glass/Polymer Forensics Evaluations Study the nature, structure and physical properties of glass and polymer containers and their responses to applied forces. Test material samples for tolerance under tension, compression and shear, to determine the cause of failures. Test individual parts and products to ensure that manufacturer and governmental quality and safety standards are met. Evaluate and interpret results using imaging acquisition equipment. Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision. Operate specialized laboratory equipment and computers as appropriate. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete laboratory routine technical tasks. Complete complex or novel assignments requiring development of new and/or improved scientific/engineering techniques and procedures. Monitor and maintain inventory of supplies and sample inventory. Coordinate and review work with peers on an ongoing basis. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Must be independent, self-motivated, organized, able to multi-task in laboratory environments, and skilled in communication, facilitation, and collaboration. Individual must be team players prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Apply knowledge of scientific/engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields. Generates robust and reliable data in compliance with the respective protocols or SOPs. Support commissioning and qualification activities Share knowledge to develop teammates in expertise discipline.

Requirements

Must be independent, self-motivated, organized, able to multi-task in laboratory environments, and skilled in communication, facilitation, and collaboration.
Individual must be team players prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Must have demonstrated skills and competencies in the following areas: o Verbal communication, English and Spanish o Written communication in English and Spanish including technical writing skills, negotiation, and conflict resolution. o Analytical problem-solving o Project management o Operational Excellence o Ability to be flexible and manage changes. o Computer literacy (Windows environment: Word, Excel, Power Point). o Skills required the application of scientific method. o Creative skills in the design and performance of scientific experiments and interpretation of results o Strong knowledge of cGMP’s o Details oriented. o Good teamwork skills o Time management o Flexible schedule o Sense of urgency o Completion and follow-up o Familiarized with electronic laboratory notebook systems.

Nice To Haves

Educational background in Engineering and/or Sciences
Knowledge in Material Sciences (glass/polymers)
Knowledge of the practical application of engineering, sciences, and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
Knowledge and prediction of physical principles, laws, interrelationships, and applications to understanding fluid, material, and atmospheric dynamics, and mechanical, electrical, atomic and sub-atomic structures and processes.
Understanding of equipment commissioning and qualification, validation and documentation processes in a highly regulated environment
Familiarity with Biopharmaceutical Environment
Knowledge in Primary Packaging Components (vials, syringes, cartridges, etc.)
Knowledge in Secondary Packaging Components (labels, dispensing cartons, blisters, etc.)
Knowledge in Glass/Polymer Forensics
Advanced scientific analysis and troubleshooting skills.
Able to work in a laboratory environment
Advanced laboratory work skills
Experience using laboratory equipment (i.e., stereomicroscopes, calipers, X-Ray/CT Scan Equipment, Instron Machine, etc.)
Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
Ability to interpret and apply GMPs.
Adheres to company policies and procedures to ensure a continuous state of compliance.
Familiarity with documentation in a highly regulated environment
Able to interact effectively with variety of communications and working styles.
Using scientific rules and methods to solve problems.

Responsibilities

Monitors field of expertise, including literature and technology development, and communicates relevant observations.
Understands and interprets primary components specifications and methods.
Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.
Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.
Introduces advanced scientific methods.
Develops and implements new and novel protocols to address specific issues.
Represents the department on project teams under supervision.
Initiates productive collaborations within and outside of the Process Development Department and Client Network.
Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Participates with the external scientific community.
Assumes lead role in department-wide support efforts such as safety, OE and other committees.
Develops and follows timelines for completing project teamwork.
Conduct research into the structures and properties of materials, such as metals, polymers, and ceramics to obtain information that could be used to develop new products or enhance existing ones.
Determine ways to strengthen or combine materials or develop new materials with new or specific properties for use in a variety of products and applications.
Develop testing methods to evaluate the effects of various conditions on containers materials.
Plan laboratory experiments to confirm feasibility of processes and techniques used in the production of materials having special characteristics.
Perform experiments, records, organize data and analyze results under minimal supervision.
Generates robust and reliable data in compliance with the respective protocols, methods or SOPs.
Identifies container components defects and provides solutions related to possible technical problems of moderate scope and complexity.
Performs Container Defects, Primary Packaging and Glass/Polymer Forensics Evaluations.
Studies the nature, structure and physical properties of glass and polymer containers and their responses to applied forces.
Tests material samples for tolerance under tension, compression and shear, to determine the cause of failures.
Tests individual parts and products to ensure that manufacturer and governmental quality and safety standards are met.
Evaluates and interprets results using imaging acquisition equipment.
Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
Operates specialized laboratory equipment and computers as appropriate.
Performs assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiates and completes laboratory routine technical tasks.
Completes complex or novel assignments requiring development of new and/or improved scientific/engineering techniques and procedures.
Monitors and maintains inventory of supplies and sample inventory.
Coordinates and reviews work with peers on an ongoing basis.
Supports a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Applies knowledge of scientific/engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
Supports commissioning and qualification activities.
Shares knowledge to develop teammates in expertise discipline.