ROLE-BASEDTALENT PLANNING
FOR OPERATIONALREADINESS
Part III in a series of papers on Operational
Excellence in the Life Sciences
By Harry Benson

A CAI E-Publication

34568ROLE-BASEDTALENT PLANNING
FOR OPERATIONALREADINESS
As capital projects and technology transfers wrap up
and facilities grow nearer to startup, site leaders andteam members may be filled with a sense of excitement
or dread depending on their confidence in the site’s
operational readiness. Among the many workstreamsof focused effort required to achieve readiness, theacquisition, placement, performance support, andretention of experts, supervisors, and staff for each
operational department can be particularly vexing. Thereis a certain “chicken-and-egg” element to staffing for
operations because of budgeting factors and uncertainty
about timing. An experienced team is needed first totranslate the process to operations at the plant and systemlevel, to map the production process to a set of job roles,and develop procedures and qualifications to control
the variability risks of those roles and achieve sustainedtargeted output and release before the real hiring andtraining can begin. It is essential that site leadership builds
a talent plan and begins the staffing process, including
appropriate budgeting, early enough to hit the verticalstartup objectives described in Part I of our Operational
Readiness series.

Role-based Talent Planning for Operational Readiness3

This paper intends to provide guidance on talent planning, withspecific emphasis on role clarity. Given the flurry of activity being
conducted during capital projects and transitions to operations,developing a talent plan may appear to be somewhat administrative
or insufficiently urgent. This often leads site leaders to foregoa focused and thoughtful talent planning process, treating the“people” workstream of Operational Readiness as a purely tacticalstaffing effort assigned to recruiting and HR and possibly withinsufficient ownership from operational workstream leaders.
The unfortunate results are too common in the life sciencesindustry: recruiting scrambles; urgent cross-training due toa shortage of qualified and/or proficient staff; startup andproduction delays due to insufficient expertise in transferringor scaling to the existing production facility; and unsustainable
costs during engineering and early production runs assupervisors and staff perform heroic efforts to produce eachbatch; each product release becomes mired in deviations from“human error”. The causes of these and other outcomes arerooted in an insufficient emphasis on the site’s talent plan. Just
as thoroughly constructed and well-executed tech transfersand master validation plans are effective in controlling risks
to process/procedure and plant variability, a well-designed
and executed talent plan provides the best risk control for thevariability the “people” aspect of sustained full-scale operations(Figure A).
PRODUCTION VARIABILITY AND CONTROL(Figure A)

SITE PRODUCTION VARIABLES

PeopleProcedures

PhysicalPlant

QUALITY SYSTEM CONTROLS
Role-based Talent Planning for Operational Readiness

4PRODUCTS

THE WORKSTREAMS OF OPERATIONAL READINESS(Figure B)

QA &Regulatory
Facilities,
Equipment,
Utilities

IT & Data
Integrity

Operations& EHS

SupplyChain

SITE READINESSOrg Health& Talent(People)

Engineering
Manufacturing
Science

Quality
Control

Perhaps the clearest way to illustrate how a talent plan serves to control such risks is towork backward from the desired state of full-scale operations: the production and releaseof targeted product output with costs sustainably within budget. This state of operations
requires staff and supervisors proficient in performing their roles consistently and able torespond effectively to non-standard conditions as they occur with minimal deviations, waste,
or loss. To achieve this level of staff proficiency and responsiveness, the site requires a
training and qualification program to drive consistent performance under standard conditions
while building the knowledge and process understanding necessary to address abnormalsituations. To support this path to proficiency, the site must have clean workflows andprocedures (both SOPs and Batch Records) to support these workflows. To translate aprocess from a tech transfer to efficiently streamlined workflows with associated procedures,role designations, and staff qualifications, you need at least one experienced staff member foreach functional area – referred to as “workstreams” in Part II of our series, shown in Figure
B above. Such experienced people may be designated as System Owners, or maybe Subject
Matter Experts (SMEs). Here is where a site’s staffing plan begins as part of the talentplanning process, as shown in Figure C.
Role-based Talent Planning for Operational Readiness

5TALENT PLANNING FLOW DIAGRAM(Figure C)

Site Objectives

Process Map

i.e., production, cost targets

Work
Breakdown
Structure

Process toProcedure Map

SME & System
Owner Roles
Defined & Filed

SOPs, work instructions,& eventually batch records

i.e., tasks withineach process step

COLOR KEY:

Site Leadership

Process toRoles Map

SMEs & System Owners

Descriptions & Numbers

Map Roles &Procedures to Skills& Knowledge for
Proficiency

Qualification
Paths & Training
Content by Role

Workplace Practices& Culture to Support
Role Performance

So how far in advance should site leaders begin their talent planning? As a benchmark,production sites of all sizes and purposes take as much as 2 to 3 years to gain staff
proficiency for consistent full capacity production and release within the targeted costs if
consistency is reached at all. This is to be expected given that procedures and training are
frequently assigned for development somewhat randomly to various team members as
collateral duties among all the other project, startup, and production activities. However, if thesite builds a talent plan that designates SME and System Owner roles in all the workstreams
required for Operational Readiness, this staff proficiency timeline can be greatly accelerated
by granting the SMEs / System Owners singular focus, authority, and organizational support
to construct all the elements needed for workstream performance excellence.
This practice of granting singular focus, authority, and organizational support can be referred
to as role clarity and is one of the top two critical factors affecting staff performance – theother being organizational purpose. These two factors are closely linked in providing a senseof meaning to inspire consistently effective performance and retention. Workplace psychology
has defined role clarity as the degree to which individuals feel they have clear guidance about
expected roles and behaviors associatedwith their job. (Kahn, Wolfe, Quinn, Snoek,and Rosenthal - 1964). There is a stronglink between role clarity and performance
because individuals who understand what is
expected from their roles can tolerate higher
levels of job demands (Lang, Thomas, Bliese,Adler – 2007). Conversely, role ambiguity
correlates to a higher degree of work stressand the resulting negative mood (Stewartand Barling – 1996), which will adversely
impact performance and retention.

Role-based Talent Planning for Operational Readiness6For role clarity to be effectively linked to organizational purpose in the mind of a given
performer, the individual must perceive a supportive work environment. This demonstrates
that the organization values that individual’s specific role in achieving the organization’spurpose. A truly supportive work environment requires an intentional focus on theperformance health, development, career progression, and retention of this personin the form of:• Well-articulated organizational purpose, vision, and measures of success• Clearly communicated priorities and performance expectations consistent
with job descriptions and metrics of success• Deliberate avoidance of conflicting or shifting priorities from all sources ofauthority (policies, procedures, site leaders and supervisors)• Stated levels and limits of authority for the role with escalating procedures• Sufficient job security and fair compensation for the level of work andassociated stresses• Reliable support resources such as systems, people, policies &procedures. This includes judgment-free outlets for expressing uncertainty
or concerns• Programs, procedures, or channels for improvements and innovations
Role-based Talent Planning for Operational Readiness

7

WORKPLACE FACTORS IMPACTING PERFORMANCE

Workplace
FactorAlignment ofPurpose & Priority
RoleClarity
Co-worker
Connections
Commitment
to Improve
Staff Development,
Qualification & Training

Description

Impact• Meaningful mission & goals+ Inspire staff• Alignment on priorities+ Productivity• Accepted definition of success- Silos, dysfunction• Clear expectations+ Steady production• Clear authority and escalation procedures- Confusion, waste• Clear workflows to achieve goal

- Exhaustion, apahty• Communication regularity, transparency & clarity+ Team collaboration• Respectful, collaborative, supportive climate+ Inter-dept. trust• Accountability at all levels- Internal politics, rumors• Staff involved in regular process & workflow review+ Quality & efficiency• Process, systems & SOP adequacy & usability+ Staff pride• Leadership attitudes / support toward change- Disengagement, silence• Strucured paths to qualify for roles / advancement+ Quality & Productivity• Opportunity for skill & career developement+ Goal-driven staff- Skill gaps, apathy

Pay &Incentives
Hiring & Advancement
Standards• Fair market value, consistent & dependable+ Valued staff, loyality• Clear expectations for advancement- Bitterness, turnover• Standards for recruiting & selection+ High standards• Fair role assignment & advancement process+ Peer respect- Resentment or burden

The above provides a summary of the workplace factors with the most impact upon job
performance, including the positive or negative impact of each effective or ineffective
workplace factor, respectively. Note that boundaries for decision-making in the form of clarity
on limits of authority and procedures for escalation of non-standard situations are importantelements of role clarity since understanding one’s degree of decision-making latitude canoffset the negative effects of increasing job demands (Karasek, 1979).
Role-based Talent Planning for Operational Readiness

8

The effectiveness of a site’s communications, within departments and cross-functionally, also
has a major effect on performance. A structured approach to site communication routines will
enhance clarity on factors that may impact one’s ability to perform. Sites should consider theuse of a RACI (Responsible, Accountable, Consulted, Informed) model that delineates whichroles are to be engaged in any given site effort – whether operational or project-based.
Additionally, using the practice of a cascading cadence of updates on status against metrics,
near-term priorities, and other site-wide messaging, the site can ensure all individuals
maintain clarity of current state vs. desired state, empowering each person to adjust theirwork efforts accordingly to best impact organizational goals.
Biotech and pharmaceutical production sites should make the elements of role clarity acultural norm throughout the organization, avoiding the tendency to distract role performancewith the “urgent” issues of the moment. Yet real issues arise on a regular basis:
unexpected QC lab results, failed integrity tests, utility or network outages, supply shortfalls,
equipment failures, human mistakes, personnel turnover, safety incidents.
One effective practice to avoid distracting focused performers from their real priorities isthe use of “Tiger Teams”. A Tiger Team is a set of versatile and creative troubleshooters andproblem solvers who can provide an “off ramp” to take ownership of such urgent issues fromtriage to full resolution as required to maintain controlled focus on the site’s larger objectives.
This approach is not uncommon in controlling workflows associated with deviations andshould be considered for all areas of non-standard workflows.

Role-based Talent Planning for Operational Readiness9

From the preceding material, along with other lessons of past and future
articles in our series, we can list the critical elements of a role-based talentplan as follows:
1. Organizational Purpose and Vision
2. Organizational Structure: identifying roles within workstreams and/or departments,
showing the alignment of resources toward achievement of purpose
3. Job Descriptions by Role: with prioritized expectations and task areas, metrics ofsuccess, and levels and limits of authority
4. Procedures and Practices for Communications: types with purpose, structure,frequency, affected roles (may be illustrated with a RACI diagram and/or a Communication
Planning Table)
5. Staffing Plan: beginning with workstream SMEs and System Owners, continuing withsupervisory and staff roles and number per role as mapped from the processes
6. Compensation Plan: categorized and bracketed for fairness and consistency
7. Onboarding and Orientation Program: for a consistent level of initial clarity for all
employees of all backgrounds and levels of experience
8. Role-based Training and Qualification Program: setting a consistent structure forestablishing role-based curricula and content
9. Organizational Support Program: comprehensive explanation of resources focused on
maximizing the success of each employee in their role while inspiring their improvement
and innovation contributions and their professional and career development
10. Succession and Knowledge Management Plan

Kahn, R. L., Wolfe, D. M., Quinn, R. P., Snoek, J. D., & Rosenthal, R. A. (1964). Occupational stress: Studies in role conflict andambiguity. New York: Wiley.
Lang, J., Thomas, J. L., Bliese, P. D., Adler, A. B. (2007), Job Demands and Job Performance: The Mediating Effect ofPsychological and Physical Strain and the Moderating Effect of Role Clarity. Journal of Occupied Health Psychology.
Stewart, W., & Barling, J. (1996). Daily work stress, mood and interpersonal job performance: A mediational model. Work andStress.
Karasek, R. A., Jr. (1979). Job demands, job decision lati- tudes, and mental strain: Implications for job redesign. Administrative
Science Quarterly.

Role-based Talent Planning for Operational Readiness

10

Harry Benson
Director Human Performance Services
Serving as the Director Human Performance Services
at CAI, Harry Benson leads a team of experienced
professionals in developing and executing programs,
processes, and tools with our clients to standardize
and improve the performance of their people. Aformer nuclear-trained submarine officer and Master
Training Specialist, he is an expert in learning solutions
design and delivery with over 20 years of experiencein applying current methods for organizational
effectiveness and learning within highly technicalenvironments. His methods have led to major skill improvement, driving results-based
performance for the U.S. Nuclear Navy and companies ranging from small to Fortune
500. Mr. Benson has a Bachelor’s degree from the U.S. Naval Academy, and a Master’sin International Business Administration from Wright State University. He is a specialist
in organizational culture and structure, human performance, adult learning, training
program development, and data center infrastructure design and operations.

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